SRK-181 + Anti-PD-(L)1 for Cancer

Recruiting in Palo Alto (17 mi)

+22 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Scholar Rock, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a multi-center, open-label, Phase 1, first-in-human (FIH), dose-escalation, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SRK-181 administered alone and in combination with anti-PD-(L)1 therapy in adult patients with locally advanced or metastatic solid tumors. The study is divided into 3 treatment parts (Part A1, Part A2, and Part B) and a Long-Term Extension Phase (LTEP).

Eligibility Criteria

This trial is for adults with advanced solid tumors who haven't responded to anti-PD-(L)1 therapy, have measurable disease, and no suitable standard care options. They must be in good physical condition with a life expectancy of at least 3 months. Women must test negative for pregnancy and agree to birth control measures.

Inclusion Criteria

I agree to use birth control during and for 3 months after the trial.

I am a woman who can have children and have a negative pregnancy test.

I can carry out all my usual activities without help.

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Exclusion Criteria

I am currently on cancer treatment but not using anti-PD-(L)1 therapy for Part A2 or B.

I received anti-PD-(L)1 therapy less than 28 days before starting SRK-181.

I have taken targeted cancer medication recently before starting SRK-181.

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Treatment Details

Interventions

Anti-PD-(L)1 Antibody Therapy (Monoclonal Antibodies)
SRK-181 (Monoclonal Antibodies)

Trial OverviewThe DRAGON study tests SRK-181 alone or combined with anti-PD-(L)1 therapy in patients whose cancer hasn't improved after previous treatments. It's an early-phase trial assessing safety, dosage, body response, and effectiveness across multiple patient groups.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Part B: Dose ExpansionExperimental Treatment2 Interventions

In Part B, parallel cohorts of patients with Non-Small Cell Lung Cancer (NSCLC), Urothelial Carcinoma (UC), Cutaneous Melanoma (MEL), Clear Cell Renal Cell Carcinoma (ccRCC), Head and Neck Squamous Cell Carcinoma (HNSCC), or other advanced or metastatic solid tumor type that is not NSCLC, UC, MEL, or ccRCC will be enrolled to confirm the tolerability of the RP2D of SRK-181 (determined in Part A2) and to evaluate the anti-tumor activity of SRK-181 in combination with an anti-PD-(L)1 antibody therapy.

Group II: Part A2: Dose EscalationExperimental Treatment2 Interventions

Part A2 will determine the MTD or MAD of SRK-181 in combination with anti-PD-(L)1 antibody therapy and will determine the RP2D of SRK-181 in combination with anti-PD-(L)1 antibody therapy for use in Part B.

Group III: Part A1: Dose EscalationExperimental Treatment1 Intervention

Part A1 will determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of SRK-181 as a single agent and will determine the recommended Phase 2 dose (RP2D) of SRK-181 as a single-agent.

Group IV: Long Term Extension Phase (LTEP)Experimental Treatment2 Interventions

Patients may continue treatment in a LTEP: * Part A1: Patients may continue treatment with SRK-181 as a single agent at the RP2D in the LTEP following 3 cycles of treatment with SRK-181 as a single agent in Part A1. * Part A2: Patients may continue treatment with SRK-181 at the RP2D in combination with anti-PD-(L)1 antibody therapy in the LTEP following 3 cycles of treatment with SRK-181 in combination with anti-PD-(L)1 antibody therapy in Part A2. * Part B: Patients may continue treatment with SRK-181 in combination with anti-PD-(L)1 antibody therapy following 9 cycles of treatment with SRK-181 in combination with anti-PD-(L)1 antibody therapy in Part B