230 Participants Needed

ASTX660 for Cancer

Recruiting at 68 trial locations
LW
PM
Overseen ByPurvi Monani
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Taiho Oncology, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing ASTX660, a new drug for patients with advanced cancers who have no other treatment options. It works by blocking proteins that help cancer cells survive, making it easier to kill them.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot take certain treatments like chemotherapy, radiotherapy, or monoclonal antibodies within a specific time before starting the trial. It's best to discuss your current medications with the trial team.

What safety data is available for ASTX660 in humans?

There is no specific safety data available for ASTX660 in the provided research articles.12345

How is the drug ASTX660 unique for treating cancer?

ASTX660 is unique because it targets specific proteins involved in cancer cell survival, potentially offering a new approach for patients who do not respond to standard treatments like doxorubicin, which is often ineffective for certain cancers such as undifferentiated soft tissue sarcoma.678910

Who Is on the Research Team?

JT

Jason Taylor, MD, PhD

Principal Investigator

Astex Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

Adults with advanced solid tumors or lymphoma that can't be removed by surgery and have no standard life-prolonging treatments available. They must have acceptable organ function, not be pregnant or breastfeeding, agree to use effective contraception, and not have other serious health issues that could affect their safety or the study results.

Inclusion Criteria

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.
See 7 more

Exclusion Criteria

My brain metastases are stable or have been treated.
I have HIV or active hepatitis B or C.
I do not have severe nerve pain or damage.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 - Dose Escalation

Dose-escalation stage to identify the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) using a 3+3 study design.

Up to 78 months
7 days on/7 days off every 28-day cycle

Phase 1 - Dose Expansion

Dose-expansion stage to confirm tolerability of ASTX660 at the RP2D.

Up to 78 months

Phase 2 - Treatment

Evaluation of ASTX660 activity in selected tumor types, including PTCL, HNSCC, DLBCL, CTCL, and cervical carcinoma.

Up to 84 months

Follow-up

Participants are monitored for safety and effectiveness after treatment.

Up to 84 months

What Are the Treatments Tested in This Trial?

Interventions

  • ASTX660
Trial Overview ASTX660 is being tested in this Phase 1/2 trial to find the safest dose, see how well it works against certain cancers, and understand its effects on the body. Participants will receive ASTX660 directly without comparison to another drug.
How Is the Trial Designed?
9Treatment groups
Experimental Treatment
Group I: Phase 2 - Cohort 6Experimental Treatment1 Intervention
Group II: Phase 2 - Cohort 5Experimental Treatment1 Intervention
Group III: Phase 2 - Cohort 4Experimental Treatment1 Intervention
Group IV: Phase 2 - Cohort 3Experimental Treatment1 Intervention
Group V: Phase 2 - Cohort 2Experimental Treatment1 Intervention
Group VI: Phase 2 - Cohort 1Experimental Treatment1 Intervention
Group VII: Phase 1 - Part 3 (optional)Experimental Treatment1 Intervention
Group VIII: Phase 1 - Part 2 (completed)Experimental Treatment1 Intervention
Group IX: Phase 1 - Part 1 (completed)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Taiho Oncology, Inc.

Lead Sponsor

Trials
79
Recruited
12,700+

Tim Whitten

Taiho Oncology, Inc.

Chief Executive Officer since 2018

MBA and Pharmacy degree

Harold Keer

Taiho Oncology, Inc.

Chief Medical Officer

MD, PhD

Astex Pharmaceuticals, Inc.

Lead Sponsor

Trials
97
Recruited
7,400+

Dr. Harren Jhoti

Astex Pharmaceuticals, Inc.

Chief Executive Officer since 2007

PhD in Biochemistry from Birkbeck College, London

Dr. Harold N. Keer

Astex Pharmaceuticals, Inc.

Chief Medical Officer since 2020

MD

Published Research Related to This Trial

A total of 3120 adverse event cases related to avapritinib were reported to the FDA, with 44% occurring within the first 30 days of treatment, highlighting the importance of monitoring patients closely during this period.
The study found that elderly male patients are at a higher risk for serious adverse events, indicating that clinicians should exercise caution when prescribing avapritinib to this demographic.
A post-marketing pharmacovigilance study of avapritinib: Adverse event data mining and analysis based on the United States Food and Drug Administration Adverse Event Reporting System database.Rong, L., Xie, M., Jiang, M., et al.[2023]
A meta-analysis of 53 Phase II/III/IV trials involving nearly 20,000 patients revealed that molecular target anticancer drugs significantly increase the risk of serious adverse events (SAEs) by 57% and fatal adverse events (FAEs) by 51% compared to placebo.
The overall incidence rates for SAEs and FAEs were found to be 26.9% and 2.3%, respectively, highlighting the need for careful monitoring and preventive measures for patients receiving these treatments.
Risk of serious adverse event and fatal adverse event with molecular target anticancer drugs in cancer patients: A meta-analysis.Wang, Z., Yang, X., Wang, J., et al.[2020]
A review of 12 targeted anticancer drugs revealed that 39% of serious adverse drug reactions (ADRs) and 39% of potentially fatal ADRs were not reported in the corresponding pivotal randomized clinical trials (RCTs), highlighting a gap in safety information for oncologists.
After a median of 4.3 years post-approval, 42% of these drugs received boxed warnings from the FDA, indicating that significant safety concerns can emerge long after initial approval and may not be adequately addressed in early clinical trial reports.
Reporting of serious adverse drug reactions of targeted anticancer agents in pivotal phase III clinical trials.Seruga, B., Sterling, L., Wang, L., et al.[2022]

Citations

A post-marketing pharmacovigilance study of avapritinib: Adverse event data mining and analysis based on the United States Food and Drug Administration Adverse Event Reporting System database. [2023]
Risk of serious adverse event and fatal adverse event with molecular target anticancer drugs in cancer patients: A meta-analysis. [2020]
The reporting of adverse events in oncology phase III trials: a comparison of the current status versus the expectations of the EORTC members. [2020]
Safety Pharmacology of Anticancer Agents. [2015]
Reporting of serious adverse drug reactions of targeted anticancer agents in pivotal phase III clinical trials. [2022]
Patterns of sensitivity to a panel of drugs are highly individualised for undifferentiated/unclassified soft tissue sarcoma (USTS) in patient-derived orthotopic xenograft (PDOX) nude-mouse models. [2020]
Individualized doxorubicin sensitivity testing of undifferentiated soft tissue sarcoma (USTS) in a patient-derived orthotopic xenograft (PDOX) model demonstrates large differences between patients. [2020]
T-LAK cell-originated protein kinase (TOPK): an emerging prognostic biomarker and therapeutic target in osteosarcoma. [2022]
P16 protein expression as a useful predictive biomarker for neoadjuvant chemotherapy response in patients with high-grade osteosarcoma: A systematic meta-analysis under guideline of PRISMA. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Addressing Modern Diagnostic Pathology for Patient-Derived Soft Tissue Sarcosphere Models in the Era of Functional Precision Oncology. [2023]
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