Melanoma Clinical Trial

SRK-181 Alone or in Combination With Anti-PD-(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON)

Summary

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).

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Patient has a histologically documented solid tumor that is metastatic or locally advanced, for which SoC therapy does not exist, has failed in the patient, or is not tolerated by the patient, or for which the patient has been assessed by the Investigator as not being a suitable candidate or otherwise ineligible for the SoC therapy.

For Part A2:

o Patient must have a history of anti-PD-(L)1 antibody nonresponse presenting (based upon the Investigator's assessment) either as progressive disease or stable disease (e.g., not improving, but also not worsening, clinically or radiographically) after at least 3 cycles of treatment with the most recent anti-PD-(L)1 antibody therapy (alone or in combination with chemotherapy) approved for that tumor type. (Note: if the duration of prior anti-PD-1 therapy is shorter than 3 cycles and the reason for discontinuation is progressive disease, the progression should be associated with clinical deterioration.)

For Part B Cohort NSCLC, UC, MEL and ccRCC:

Patient must be diagnosed with one of the following disease-specific solid tumors of NSCLC, UC, or MEL, and must have a history of primary nonresponse to anti-PD-1 therapy (alone or in combination with other therapy), presenting the best response (based upon the Investigator's assessment) either as progressive disease or stable disease (e.g., not improving, but also not worsening, clinically or radiographically) after at least 3 cycles of treatment.
For Cohort NSCLC, patients who have genomic tumor aberrations for which a targeted therapy is available (e.g., anaplastic lymphoma kinase, EGFR) must have progressed on an approved therapy for these aberrations or did not tolerate an approved therapy for these aberrations, or were not considered suitable candidates/ were otherwise ineligible for an approved therapy for these aberrations.
For Cohort ccRCC, patients must have a histologically confirmed diagnosis of RCC with a predominant clear cell component and must have received at least 1 prior line of anti-PD-1 treatment (alone or in combination with other therapy) and have had disease progression clinically or radiographically on the most recent anti-PD-1 treatment
Up to 3 lines of treatment are allowed between the last dose of anti-PD-1 and enrollment.
For Part B Cohort Any Other: Patient must be diagnosed with any other solid tumor type that is not NSCLC, UC, MEL, or ccRCC for which the patient has had a history of primary anti PD (L)1 antibody nonresponse, presenting the best response (based upon the Investigator's assessment) as progressive disease, after prior anti-PD-(L)1 antibody therapy (alone or in combination with other therapy) currently approved for that tumor indication
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed at Screening.
Patient must have an Eastern Cooperative Oncology Group performance status (PS) 0-1.
Patient must have a predicted life expectancy of ≥ 3 months.
Women of child-bearing potential (WOCBP) must have a negative urine or serum pregnancy test up to 24 hours prior to first dose of SRK-181.
WOCBP and males with female partners of childbearing potential must agree to use adequate birth control throughout their participation and for 90 days following the last dose of SRK-181.

Key Exclusion Criteria:

For Part A1 only:

Patient has had anti-PD-(L)1 antibody therapy ≤ 28 days prior to the first dose of SRK-181.
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.

For Part A2 and Part B only:

Patient is receiving concurrent anti-cancer treatment, with the exception of an anti-PD-(L)1 antibody therapy for Part A2 or Part B, either approved or investigational, within 28 days prior to the first dose of SRK-181.
Patient has received biologic therapy (except for anti-PD-(L)1 antibody therapy for Part A2 or Part B), <28 days prior to the first dose of SRK-181.
Patient has received systemic cytotoxic chemotherapy (except for in combination with anti-PD-(L)1 antibody therapy) <28 days prior to the first dose of SRK-181.
Patient has received targeted small molecule therapy within 5 half-lives of the compound prior to the first dose of SRK-181.
Patient has a history of intolerance or treatment discontinuation due to severe irAE or other adverse reaction from prior anti-PD-(L)1 antibody therapy.
Patient has a hypersensitivity to anti-PD-(L)1 antibody therapy.
Patient has the documented presence of neutralizing ADA to anti-PD-(L)1 antibody therapy.
Patient has a diagnosis of immunodeficiency, either primary or acquired.
Patient is symptomatic or has uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation.
Patient has current second malignancy at other sites (exceptions: adequately treated in situ carcinoma [e.g., cervical], non-MEL skin cancer, bilateral synchronous discordant breast cancer, or indolent prostate cancer under observation). A past history of other malignancies is allowed as long as patient has been free of recurrence for ≥ 2 years, or if the patient has been treated with curative intent within the past 2 years and, in the opinion of the Investigator, is unlikely to have a recurrence.
Women who are pregnant or breastfeeding.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

200

Study ID:

NCT04291079

Recruitment Status:

Recruiting

Sponsor:

Scholar Rock, Inc.

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There are 12 Locations for this study

See Locations Near You

St. Jude Crosson Cancer Institute
Fullerton California, 92835, United States More Info
Linda Gozar, MPH
Contact
714-446-5177
David J Park, MD
Principal Investigator
Innovative Clinical Research Institute
Los Angeles California, 90603, United States More Info
Leslie Posadas
Contact
562-693-4477
[email protected]
Arati Chand, MD
Principal Investigator
H. Lee Moffitt Cancer Center& Research Institute
Tampa Florida, 33612, United States More Info
Karina Gonzalez Bonilla, MPH, BSN, BS
Contact
813-745-3246
[email protected]
Ahmad Tarhini, MD, PhD
Principal Investigator
University of Chicago
Chicago Illinois, 60637, United States More Info
Eli Gussen
Contact
773-702-4193
[email protected]
Randy Sweis, MD
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02115, United States More Info
Justin L Gainor, MD
Contact
617-724-4000
[email protected]
Justin L Gainor, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02155, United States More Info
Bruno Bockorny, MD
Contact
617-667-2100
[email protected]
Bruno Bockorny, MD
Principal Investigator
University of Michigan
Ann Arbor Michigan, 48109, United States More Info
MET-Referrals
Contact
[email protected]
Ulka Vaishampayan, MD
Principal Investigator
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States More Info
Eugenia Hasenecz, RN
Contact
412-623-5253
[email protected]
Jason Luke, MD, FACP
Principal Investigator
Tennessee Oncology, Sarah Cannon Research Institute
Nashville Tennessee, 37201, United States More Info
Study Coordinator
Contact
615-329-7413
Meredith McKean, MD
Principal Investigator
BUMC Mary Crowley Cancer Research Centers
Dallas Texas, 75230, United States More Info
Study Coordinator
Contact
214-658-1944
Minal Barve, MD
Principal Investigator
The University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Timothy Yap, MD
Contact
713-563-1930
Timothy Yap, MD
Principal Investigator
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Cassandra Kujawa
Contact
414-805-8839
[email protected]
Jaydah Gonzalez
Contact
[email protected]
Deepak Kilari, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

200

Study ID:

NCT04291079

Recruitment Status:

Recruiting

Sponsor:


Scholar Rock, Inc.

How clear is this clinincal trial information?

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