ISM3091 for Solid Tumors

Recruiting at 30 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

425 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called XL309, either by itself or with another drug called olaparib. It targets people with advanced solid tumors to see if the drug can stop or slow down cancer growth. Researchers are also checking if combining XL309 with olaparib makes it more effective. Olaparib is a type of drug approved for treating various cancers, including ovarian and breast cancer, particularly in patients with certain genetic conditions.

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.

Eligibility Criteria

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 organs and bone marrow are working well.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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

Participants will receive XL309 once daily in sequential cohorts of increasing doses.

Group II: Dose Escalation Combination Therapy Experimental Treatment 2 Interventions

Participants will receive XL309 once daily in sequential cohorts of increasing dose 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