ISM3091 for Solid Tumors

Recruiting at 28 trial locations

Overseen By Exelixis Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: InSilico Medicine Hong Kong Limited

Must not be taking: Antibody therapy, Chemotherapy

Disqualifiers: Brain metastases, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

429 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment, XL309 (also known as ISM3091), used alone or with another drug, olaparib, in individuals with advanced solid tumors. Researchers seek to understand how the body processes XL309 and its effects on tumors. The trial is recruiting participants with specific types of advanced cancers, such as breast or ovarian cancer, that have not responded to standard treatments or have particular genetic traits. Those dealing with advanced cancer that is difficult to treat and have specific genetic mutations may find this trial suitable. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does require a waiting period after certain treatments before starting the study. For example, you must wait 3 weeks after chemotherapy or small molecule-targeted therapy and 1 week after radiation therapy before beginning the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ISM3091 is being tested for safety in people with advanced solid tumors. As this is the first human trial of ISM3091, no previous human data exists. The current Phase 1 trial examines how well people tolerate ISM3091 alone and in combination with another drug, olaparib.

This phase typically assesses potential side effects and their severity. ISM3091 remains under study and lacks FDA approval for any conditions, so its safety profile is still being determined. Participants contribute to understanding its safety and potential side effects.

In summary, the trial focuses on the safety and tolerability of ISM3091. Participants play a crucial role in helping researchers gather this important information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

ISM3091 is unique because it targets advanced solid tumors with a new approach, potentially offering an alternative to standard chemotherapy and targeted therapies like monoclonal antibodies. Unlike most treatments that often rely on these conventional mechanisms, ISM3091 is being tested both as a single agent and in combination with olaparib, a PARP inhibitor known for its role in treating cancers with specific DNA repair deficiencies. Researchers are excited about ISM3091 because its novel combination approach might enhance treatment efficacy and overcome resistance that often develops with existing therapies.

What evidence suggests that this trial's treatments could be effective for solid tumors?

Research has shown that ISM3091 might help treat advanced solid tumors. This new drug targets specific parts of cancer cells, offering a promising option for patients. In this trial, participants will receive ISM3091 either alone or with olaparib. Early studies suggest that ISM3091, when used alone, may shrink tumors or halt their growth. Combined with olaparib, a drug already used in some cancer treatments, it might enhance effectiveness. Although more research is needed, early findings offer hope for treating difficult cancers. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced breast, ovarian, or prostate cancer that's worsened after standard treatment or when no other therapy is suitable. They must be in relatively good health otherwise, understand the study and agree to participate by signing a consent form.

Inclusion Criteria

Patient should understand, sign, and date the written informed consent form (ICF) prior to screening

My cancer has a BRCA mutation and didn't respond well to PARPi treatment or is HRD+.

My organs and bone marrow are working well.

Exclusion Criteria

I have not had radiation therapy in the last 4 weeks.

I haven't had antibody therapy in the last 4 weeks or within its 5 half-lives period.

I have a heart condition as defined in the study protocol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive XL309 once daily in sequential cohorts of increasing doses, alone or in combination with olaparib

24 months

Cohort Expansion

The recommended dose from the escalation stage is further studied in advanced solid tumor-specific cohorts, alone or in combination with olaparib

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ISM3091

Trial Overview ISM3091, a new drug for treating solid tumors, is being tested. The trial has two parts: first finding the right dose and then confirming it's safe and effective. It's an early-stage study (Phase I) involving patients from multiple centers.

How Is the Trial Designed?

Group I: Dose Escalation Single Agent Evaluation Experimental Treatment 1 Intervention

Participants will receive XL309 in sequential cohorts of increasing doses.

Group II: Dose Escalation Combination Therapy Experimental Treatment 2 Interventions

Participants will receive XL309 in sequential cohorts of increasing doses in combination with olaparib.

Group III: Cohort Expansion Stage Single Agent Evaluation Experimental Treatment 1 Intervention

The recommended dose as determined in the Escalation Stage will be further studied in advanced solid tumor-specific cohorts.

Group IV: Cohort Expansion Stage Combination Therapy Evaluation Experimental Treatment 2 Interventions

The recommended dose as determined in the Escalation Stage will be further studied in combination with olaparib in advanced solid tumor-specific cohorts.

Who Is Running the Clinical Trial?

InSilico Medicine Hong Kong Limited

Lead Sponsor

Trials

9

Recruited

1,100+

Exelixis

Lead Sponsor

Trials

126

Recruited

20,500+

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05932862

NCT05932862 | A Phase 1 Study of XL309 (ISM3091) ... This is a first-in-human (FIH), multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20578103

A Phase 1 Study of XL309 (ISM3091) Alone and in ... This is a FIH, multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as PK and ...

3. uhhospitals.org uhhospitals.org/uh-research/find-clinical-trials-and-studies/clinical-trials-search/study-of-xl309-ism3091-in-patients-with-advanced-solid-tumors-20136

Study of XL309 (ISM3091) in Patients With Advanced Solid ... This is a first-in-human (FIH), multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as ...

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/421155

A Phase 1 Study of XL309 (ISM3091) Alone and in ... This is a first-in-human (FIH), multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, ...

5. facingourrisk.org facingourrisk.org/research-clinical-trials/study/300/study-of-a-new-investigationai-inhibitor-to-treat-people-with-advanced-solid-tumors

Study of a New Investigational Inhibitor to Treat People ... The study will test if an investigational treatment, XL309, is safe and works when used alone or in combination with a PARP inhibitor to treat people with some ...

6. ir.exelixis.com ir.exelixis.com/news-releases/news-release-details/exelixis-and-insilico-medicine-enter-exclusive-global-license

Exelixis and Insilico Medicine Enter into Exclusive Global ... On April 17, 2023 , the FDA cleared the initial IND for ISM3091 for the treatment of patients with solid tumors. About Insilico Medicine.

7. exelixismedicalaffairs.com exelixismedicalaffairs.com/explore-our-pipeline/explore-xl309/

XL309 USP1 Inhibitor This website includes information on investigational uses of compounds that have not been approved by the U.S. Food and Drug Administration (FDA). Safety and ...

8. trialx.com trialx.com/clinical-trials/listings/235960/a-phase-1-study-of-xl309-ism3091-alone-and-in-combination-in-patients-with-advanced-solid-tumors/

A Phase 1 Study of XL309 (ISM3091) Alone and in ... This is a FIH, multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as PK and ...