No Placebo-Only Group

This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for whom standard life-prolonging measures are not available.

Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas

ASTX660 for Cancer

This study is evaluating whether ASTX660 may be effective in treating cancer.

My brain metastases are stable or have been treated.

My cancer is advanced, cannot be surgically removed, and has no standard treatment options.

My lymphoma is CD30-positive and I can't use or have already used brentuximab vedotin.

I have mycosis fungoides or Sezary syndrome and cannot take mogamulizumab.

I do not have severe nerve pain or damage.

I have other serious health conditions besides my current illness.

I do not have any severe illnesses or conditions that could risk my safety or affect the study results.

I have a history of heart problems or am at risk for them.

I can take care of myself and am up and about more than half of my waking hours.

I am following the birth control requirements outlined in the study.

My organ functions are within normal ranges according to recent tests.

I haven't had cancer treatment within the required time before starting ASTX660.

My disease is worsening and I've had at least two treatments before.

My cancer is a specific type of lymphoma recognized by the WHO.

ASTX660

This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

Entrectinib for Solid Tumors

This study is evaluating whether a drug may help treat tumors with certain gene fusions.

I have been treated with specific inhibitors for my cancer due to certain gene changes.

My cancer can be measured or seen on tests.

I finished my radiotherapy more than 14 days ago.

My cancer is advanced and tests positive for specific genetic changes.

I have a family or personal history of bone disorders.

I am still recovering from a recent surgery.

I have had heart failure symptoms or a low heart pump function in the last 3 months.

I have a history of long QT intervals not caused by medication.

I have risk factors for irregular heartbeats.

My brain involvement from cancer is either symptom-free or was treated and is now under control.

I have lung scarring or inflammation from previous treatments.

I have moderate to severe numbness, tingling, or pain in my hands or feet.

I have a condition that affects my stomach or intestines' ability to absorb nutrients.

I can provide a tissue sample for testing unless it's medically unsafe for me.

I have had cancer treatment but not with Trk, ROS1, or ALK inhibitors for specific gene changes.

It's been over 2 weeks since my last cancer treatment.

It has been over 4 weeks since my last antibody therapy.

I can care for myself and doctors expect me to live at least another month.

I have no other cancers that would affect this trial's results.

Entrectinib

This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion (eNRGy)

A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)

Zenocutuzumab for Solid Tumors

This study is evaluating whether a drug may help treat cancer.

Your liver enzyme levels and bilirubin levels should be within certain limits. If you have liver spread of cancer, slightly higher levels are allowed. If you have Gilbert's syndrome, higher bilirubin levels are allowed.

I can provide a new or old sample of my tumor for testing.

You are expected to live for at least 12 more weeks.

I have HIV or untreated Hepatitis B, or I've been treated for Hepatitis C with no detectable virus now.

I have brain metastases that are causing symptoms or are unstable.

I have a fever or infection that isn't under control.

I have heart issues like heart failure, low heart pump function, or serious heart rhythm problems.

I had cancer before, but it was treated over 2 years ago.

I have at least one tumor that can be measured or my disease can be evaluated in another specific way.

I have recovered from major surgery with minimal side effects.

My white blood cell count is healthy without needing medication for the past week.

I am able to care for myself and perform daily activities.

I will use birth control during and for 6 months after the study.

I haven't taken any cancer drugs or experimental medications recently.

My platelet count is healthy without needing a transfusion in the last week.

My cancer is advanced, cannot be surgically removed, and has an NRG1 gene fusion.

Your doctor thinks you will live for at least 12 more weeks.

Your kidney function is good, with a GFR of more than 30 mL/min.

My cancer has spread to the lining of my brain and spinal cord.

You are allergic to any of the ingredients in MCLA-128.

Side effects from my previous cancer treatments are mild.

I have undergone or am considered unsuitable for standard cancer treatments.

Your hemoglobin level needs to be at least 8 g/dL or 5 mmol/L.

Zenocutuzumab (MCLA-128)

A phase 1, dose escalation study of evorpacept (ALX148) in patients with advanced solid tumors and lymphoma

A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)

Evorpacept for Cancer

This study is evaluating whether a drug called evorpacept can be safely given to people with cancer.

You have received strong chemotherapy in the past that required a stem cell transplant.

You have received treatment with a specific type of medication that targets CD47 or SIRP alpha proteins in the past.

You have been diagnosed with an advanced or metastatic solid tumor or a type of Non-Hodgkin lymphoma that has come back or is not responding to standard treatments.

You have cancer that has spread to your brain or spinal cord and is causing symptoms. You need to take steroids to manage these symptoms.

Evorpacept (ALX148)

Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction.

Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

Repotrectinib for Solid Tumors

I have had cancer before, but it was either skin cancer treated successfully or another type that was completely removed and didn’t need treatment in the last 2 years.

My cancer is advanced and tests show specific gene changes.

I am at least 18 years old, or 20 if required by local laws.

I can swallow pills without breaking them.

All side effects from my previous cancer treatments, except for hair loss, are mild or gone.

I have brain metastases or leptomeningeal disease but no symptoms.

I do not have moderate or severe numbness, tingling, or pain in my hands or feet.

I have previously received immunotherapy.

I haven't had radiation therapy (except for bone pain relief) in the last 2 weeks.

I have brain metastases or leptomeningeal involvement that causes symptoms.

I have had serious heart problems recently.

I have severe lung scarring or disease affecting both lungs.

I have not had major surgery in the last 4 weeks.

I have a condition that affects how drugs are absorbed in my body.

I am fully active or can carry out light work.

I do not have any active infections, including HIV.

Repotrectinib (TPX-0005)

This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)

Selpercatinib for Solid Tumors

I have not had major surgery in the last 2 weeks.

I am not taking strong drugs that affect liver enzymes or forbidden medications.

I don't have severe side effects from past treatments, except for hair loss or mild nerve pain from platinum-based therapy.

My lung cancer is in an early stage, operable, and has not been treated yet.

I haven't had a heart attack in the last 6 months and my heart's electrical cycle is normal.

My cancer does not initially need a RET gene alteration, but will require it after initial treatment.

You have a disease that can be measured by specific guidelines for your type of tumor.

You are expected to live for at least 3 more months.

My blood, liver, and kidney functions are all within normal ranges.

I stopped a RET inhibitor treatment but may join with approval.

My cancer cannot be measured by standard tests.

I have not had any systemic therapy for my lung cancer.

My cancer has worsened despite treatment, or I can't tolerate/decline standard treatments.

I have previously been treated with drugs targeting multiple kinases including RET.

I can care for myself and remain up and about more than half of my waking hours.

I've had targeted radiation for symptom relief recently, but not on over 30% of my bone marrow or a wide area.

My brain or spinal cancer symptoms are stable, and I haven't had surgery or radiation recently.

I have tried or am not suited for standard treatments for my cancer type and stage.

My cancer is part of the MTC spectrum or has RET changes, pending approval.

I have previously been treated with a RET inhibitor.

I haven't taken any experimental cancer treatments recently.

My cancer has a known genetic mutation driving its growth.

I have at least one tumor that can be measured and hasn't been treated with radiation.

You do not fit the specific requirements for participating in Cohorts 3 or 4.

LOXO-292

First-in-human, Phase 1b/2 safety study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks. Patients with tumor types likely to express NaPi2b were enrolled in dose escalation. Patients with platinum-resistant ovarian cancer and non-small cell lung cancer (adenocarcinoma subtype) were enrolled in the expansion segment of this study. Patients with platinum-resistant, high-grade serous ovarian cancer were enrolled in the UPLIFT segment of this study. In addition to safety assessments, the pharmacokinetics of the drug were assessed along with ADC activity. A QTc sub-study was added for the UPLIFT cohort for a sub-set of sites.

First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b

Upifitamab Rilsodotin for Cancer

This study is evaluating whether a drug may help treat ovarian cancer.

My condition did not improve with platinum-based chemotherapy.

My heart rate is between 45 and 100, and I don't have a normal heart rhythm.

I have had 1 to 4 treatments for ovarian cancer.

All side effects from my previous treatments are mild, except for hair loss or stable conditions I'm being treated for.

I am not taking medication that strongly affects liver enzyme activity.

I have a heart valve problem that is more than moderate.

I have high-grade serous ovarian, fallopian tube, or peritoneal cancer that has spread or come back.

I have had bevacizumab as part of my first or second line of treatment.

My tumor is a specific type, such as low-grade, clear cell, or others listed.

My cancer did not respond to platinum-based chemotherapy.

I have an eye condition affecting the cornea or had one in the past year.

I am taking medication that strongly affects liver enzyme levels and cannot stop while on the study treatment.

I haven't had cancer in the last 2 years, except for certain skin cancers or cervical cancer that were treated.

I do not have any severe illnesses that could affect my trial participation.

I have had lung inflammation or scarring.

I have previously been treated with a drug similar to mirvetuximab soravtansine.

I have brain metastases that haven't been treated or a history of cancer spreading to my brain's lining.

I haven't had major surgery or cancer treatment recently.

I do not have an active infection with HIV, hepatitis B, or hepatitis C.

I am willing to provide a sample of my tumor for testing.

My blood tests and kidney function are within normal ranges, and I can make my own medical decisions.

My heart does not have uncontrolled irregular rhythms.

upifitamab rilsodotin

This study is an open-label, multi-center, dose-escalation, dose-finding and expansion study in adult subjects with advanced solid tumors for whom no standard therapy is available. The study will evaluate the safety, tolerability, PK, PD, and preliminary anti-tumor efficacy of SM08502 administered orally, once daily, following a 28-day treatment cycle (Part 1A). Alternative dosing schedules will be explored in Part 1B and the recommended Part 2 dose and schedule will be further evaluated in Part 2.

Subjects will participate in a screening period of up to 14 days. Dosing in 28-day cycles will continue within each subject, unless treatment is discontinued due to toxicity, disease progression, initiation of a new anti-neoplastic therapy, withdrawal of consent, the Sponsor terminates the study, or the subject no longer meets retreatment criteria.

Approximately 10 subjects enrolled in Part 2, irrespective of the tumor type, will be included in a food effect substudy to assess the preliminary effect of a high-fat, high-calorie meal on the PK of SM08502. Subjects participating in the food effect substudy will continue on study and complete assessments as per the Part 2 schedule and receive SM08502 at the recommended Part 2 dose (or another previously assessed dose level and schedule).

A Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors

SM08502 for Cancer

I can provide a sample of my tumor for the study.

I have brain metastasis that is untreated, getting worse, or causing symptoms.

I have a retinal condition like diabetic retinopathy or macular degeneration.

My advanced cancer hasn't responded to or I can't tolerate standard treatments.

I have an active HIV, HBV, or HCV infection.

I am fully active or have some restrictions but can still care for myself.

I haven't had a heart attack in the last year and don't have severe heart failure or significant heart disease.

My liver is not working well (Child-Pugh B or C).

I have no side effects from previous cancer treatments.

I am a man who can father children and agree to follow contraceptive guidelines.

I am currently on IV antibiotics for an infection.

I had another type of cancer but have been free of it for over 3 years.

I do not have a GI condition that affects medication absorption.

My heart's electrical system has a slight irregularity.

SM08502

The purpose of this study is to assess the safety and pharmacokinetics of boserolimab (MK-5890) when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of boserolimab monotherapy or boserolimab plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of boserolimab when administered with pembrolizumab, pemetrexed and carboplatin in adults with non squamous non-small cell lung cancer (NSCLC) and boserolimab when administered with pembrolizumab and nab-paclitaxel in adults with triple-negative breast cancer (TNBC) will also be assessed.

Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)

Boserolimab + Pembrolizumab for Advanced Cancers

This study is evaluating whether a combination of drugs may help treat solid tumors.

I had another cancer but was treated successfully and have been cancer-free for 2 years.

I have had pneumonitis treated with steroids or have it now.

I am not pregnant or breastfeeding and agree to use contraception for the required period after treatment.

You had a serious allergic reaction to a specific type of medication called monoclonal antibody (mAb).

I am fully active or restricted in physically strenuous activity but can do light work.

I have fluid buildup in my abdomen or around my lungs that causes symptoms.

I agree to use contraception and not donate sperm for up to 6 months after treatment.

You use illegal drugs regularly or have a recent history of substance abuse, unless it's for medical reasons approved by the doctor.

My advanced cancer is confirmed and I've tried or can't tolerate all known beneficial treatments.

I haven't needed treatment for an autoimmune disease in the last 2 years, except for vitiligo or childhood asthma.

I have recovered from major surgery without any significant infection.

I am on high doses of steroids or other drugs that weaken my immune system.

I have not received a live-virus vaccine in the last 28 days.

I haven't had cancer treatment in the last 4 weeks or have recovered from its side effects.

I will not need other cancer treatments during this study.

My lung cancer is non-squamous and at stage IV.

You are allergic to nab-paclitaxel or its components, have severe nerve problems, have had serious heart issues recently, or have received certain previous treatments.

My breast cancer is triple-negative, has returned, can't be surgically removed or cured, and hasn't been treated with chemotherapy.

My cancer can be measured by scans and has grown in previously treated areas.

I have had a stem cell or bone marrow transplant in the past.

You have received high-dose radiation to the lung in the past 6 months, are unable to stop taking aspirin or certain pain relievers for a short time, or cannot or do not want to take folic acid or vitamin B12 supplements.

I have a history of lung scarring or fibrosis.

You need to provide a tumor sample for analysis, either a new sample or one saved from before.

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