Surufatinib + Tislelizumab for Cancer

Recruiting in Palo Alto (17 mi)

+17 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Hutchison Medipharma Limited

No Placebo Group

Trial Summary

What is the purpose of this trial?This open-label, phase Ib/II study of surufatinib in combination with tislelizumab will evaluate the safety, tolerability, PK and efficacy in patients with advanced solid tumors. The study consists of 2 parts - dose finding (Part 1) and dose expansion (Part 2).

Eligibility Criteria

This trial is for adults with various advanced solid tumors, including specific types of stomach, colorectal, lung, thyroid cancers and sarcomas. Participants must have progressed after prior treatments and agree to use effective contraception. Exclusions include significant infections like HIV, recent serious cardiovascular events or thrombosis, previous surufatinib treatment, uncontrolled hypertension or certain autoimmune diseases.

Inclusion Criteria

I am 18 years old or older.

My stomach cancer has worsened after two treatments and tests positive for PD-L1.

My cancer has worsened in the last 3 months and I've either tried or refused standard treatment.

My cancer is a low or intermediate grade NET from the chest or gut area and has worsened in the last 6 months despite treatment.

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

My cancer is advanced or has spread and was confirmed by a lab test.

My colon or rectum cancer is stable but has not responded to at least 3 treatments.

My cancer is advanced or has spread, confirmed by lab tests.

Exclusion Criteria

My high blood pressure is not controlled by medication.

I have been treated with surufatinib before.

I have a serious heart condition.

I haven't had a stroke or blood clot in the last year.

I haven't had serious bleeding or life-threatening blood clots in the past 6 months.

I do not have any serious infections, including HIV.

My side effects from previous cancer treatments are mild or gone.

I have CRC, NETs, or STS and have been treated with specific immune therapies before.

I am not pregnant or breastfeeding.

Participant Groups

The study tests the combination of two drugs: Surufatinib and Tislelizumab in patients with advanced solid tumors. It has two parts: Part 1 finds the right dose and Part 2 expands on this dose to further assess safety and effectiveness.

2Treatment groups

Experimental Treatment

Group I: Surufatinib and tislelizumab (indication specific_Part 2)Experimental Treatment1 Intervention

In Part 2, the indication-specific expansion portion of the study, patients will receive surufatinib at the Recommended Phase 2 Dose (RP2D) dose selected in Part 1 with 200 mg tislelizumab IV, Q3W

Group II: Surufatinib and tislelizumab (dose escalation_Part 1)Experimental Treatment1 Intervention

In Part 1 (dose escalation), surufatinib and will be administered orally (PO) once daily (QD) and tislelizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W).