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Monoclonal Antibodies

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

Phase 1

Waitlist Available

Research Sponsored by Scholar Rock, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have an Eastern Cooperative Oncology Group performance status (PS) 0-1.

Be older than 18 years old

Must not have

Patient is symptomatic or has uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation.

Patient is receiving concurrent anti-cancer treatment, including anti-PD-(L)1 antibody therapy, either approved or investigational, within 28 days prior to the first dose of SRK-181.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, SRK-181, to see if it is safe and effective in treating solid tumors. The study will test different doses of the drug alone and in combination with another anti-cancer drug. The trial is divided into 3 parts, with a long-term extension phase.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as inflammation in various organs due to the drug's mechanism of enhancing immune activity against cancer cells. Specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can carry out all my usual activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have untreated or symptomatic brain metastases or spinal issues.

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I haven't had any cancer treatment, including anti-PD-(L)1 therapy, in the last 28 days.

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I am not pregnant or breastfeeding.

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I have been diagnosed with an immune system disorder.

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My body has developed resistance to a specific cancer immunotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and tolerability of SRK-181 in combination with anti-PD-(L)1 antibody therapy

Safety and tolerability of single agent SRK-181

Secondary study objectives

Anti-tumor activity of SRK-181, alone or in combination wit anti-PD-(L)1 antibody therapy as potential indicators of clinical response

PK of SRK-181 alone and in combination with anti-PD-(L)1 antibody therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 6Eligibility criteria met