Telatinib + Keytruda for Stomach and Liver Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byAndrew Hendifar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Andrew Hendifar, MD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of two drugs, telatinib and Keytruda, in patients with advanced stomach, gastroesophageal junction cancer, and liver cancer. Telatinib aims to stop cancer growth, while Keytruda helps the immune system fight the cancer. The goal is to see if this combination can help patients live longer without their cancer worsening.

Research Team

Andrew Hendifar, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

Adults with advanced stomach, gastroesophageal junction cancers or hepatocellular carcinoma that have progressed after prior treatments and are PD-L1-positive. They must be able to swallow tablets, not have uncontrolled infections or certain other health conditions, and agree to use contraception.

Inclusion Criteria

Able to swallow tablets and agree to take the prescribed tablets twice daily.

Diagnosis: Histologically confirmed gastric/esophagealgastric adenocarcinoma, recurrent, locally advanced or metastatic, PD-L1-positive disease (CPS ≥1), progressed on at least two prior lines of therapy and/or discontinued second line therapy for intolerance, indicated for Keytruda therapy. OR: Hepatocellular carcinoma with diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases criteria for patients with cirrhosis, unresectable disease not amenable to locoregional therapy with disease progression after at least one prior line of systemic therapy or discontinued first line therapy for intolerance.

At least 1 measurable metastatic lesion that has not been irradiated. The lesion will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), and be documented by radiological evaluation within 28 days prior to registration. For subjects with locally advanced disease: at least one measurable lesion that has not been irradiated, documented by radiological evaluation within 28 days prior to registration.

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Exclusion Criteria

Uncontrolled hypertension

Severe hemorrhage/bleeding event within 28 days prior to the first dose of study treatment

Major surgery, open biopsy, or significant traumatic injury within 42 days prior to the first dose of study treatment

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Treatment Details

Interventions

Keytruda (PD-1 Inhibitor)
Telatinib (Tyrosine Kinase Inhibitor)

Trial OverviewThe trial is testing the combination of Telatinib and Keytruda in patients with specific advanced cancers. It's an open-label study focusing on how these drugs affect the time a patient lives without their disease getting worse.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: telatinib + KeytrudaExperimental Treatment2 Interventions

Keytruda is already approved in Japan, Canada for the following indications: