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Monoclonal Antibodies

SRF617 for Solid Tumors

Phase 1

Waitlist Available

Research Sponsored by Surface Oncology

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial is testing a new drug, SRF617, to see if it is safe and effective in treating cancer.

Eligible Conditions

Advanced Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Limiting Toxicity of SRF617

Secondary outcome measures

Disease control rate (DCR)

Duration of response (DoR)

Effect of SRF617 on intratumoral CD39 enzymatic activity

+6 more

Trial Design

8Treatment groups

Experimental Treatment

Group I: SRF617 + Pembrolizumab + Gemcitabine + Albumin-bound Paclitaxel Quadruplet Dose ExpansionExperimental Treatment4 Interventions

Enrollment at the recommended phase 2 combination dose established in the combination dose escalation arms (if recommended phase 2 combination doses differ, the lower of the starting 2 doses will be used) may be expanded to include up to approximately 30 additional patients with advanced 1L PDAC.

Group II: Monotherapy Tumor Biopsy ExpansionExperimental Treatment1 Intervention

The monotherapy tumor biopsy expansion portion of the study will further evaluate the safety and intratumoral pharmacodynamics of SRF617 monotherapy in up to 20 patients at cleared and recommended phase 2 dose levels.

Group III: Monotherapy Dose EscalationExperimental Treatment1 Intervention

The monotherapy dose escalation portion of the study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of SRF617 as monotherapy in up to 36 patients with advanced solid tumors.

Group IV: Combination Therapy - SRF617 with Pembrolizumab Dose Expansion anti-PD-L1 GC/GEJ, PD-L1+ NSCLCExperimental Treatment2 Interventions

Enrollment at the recommended phase 2 combination dose may be expanded to include approximately 29 additional patients with anti-PD-(L) 1 relapsed/refractory PD-L1+ HER2 negative gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma or advanced PD-L1+ NSCLC to further evaluate safety with SRF617 and pembrolizumab combination therapy.

Group V: Combination Therapy - SRF617 with Pembrolizumab Dose Expansion GC/GEJExperimental Treatment2 Interventions

Enrollment at the recommended phase 2 combination dose may be expanded to include approximately 28 additional patients with 2 anti-PD-(L) 1 naive HER2 negative gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma to further evaluate safety with SRF617 and pembrolizumab combination therapy.

Group VI: Combination Therapy - SRF617 with Pembrolizumab Dose EscalationExperimental Treatment2 Interventions

This portion of the study will evaluate the safety, tolerability, PK, and preliminary efficacy of SRF617 in combination with pembrolizumab (Keytruda®) in patients with locally advanced or metastatic solid tumors.

Group VII: Combination Therapy - SRF617 with Gemcitabine + Albumin-bound Paclitaxel Dose ExpansionExperimental Treatment3 Interventions

Enrollment at the recommended phase 2 combination dose may be expanded to include approximately 10 additional patients with advanced pancreatic ductal adenocarcinoma (PDAC) to further evaluate safety with SRF617 and gemcitabine + albumin-bound paclitaxel combination therapy.

Group VIII: Combination Therapy - SRF617 with Gemcitabine + Albumin-bound Paclitaxel Dose EscalationExperimental Treatment3 Interventions

This portion of the study will evaluate the safety, tolerability, PK, and preliminary efficacy of SRF617 in combination with gemcitabine + albumin-bound paclitaxel in patients with locally advanced or metastatic solid tumors.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

SRF617

2022

Completed Phase 2

~100

Gemcitabine

2017

Completed Phase 3

~2070

Albumin-Bound Paclitaxel

2020

Completed Phase 2

~120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,486 Total Patients Enrolled

Surface OncologyLead Sponsor

5 Previous Clinical Trials

604 Total Patients Enrolled

Alison O'Neill, MDStudy ChairSurface Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has SRF617 been acknowledged by the FDA?

"Due to the limited research regarding SRF617's safety and efficacy, it was attributed a score of 1."

Answered by AI

Can you elaborate on any past experiments conducted with SRF617?

"Currently, 1980 clinical trials for SRF617 are taking place with 413 of them in the advanced Phase 3. Numerous studies centered around this drug exist in Shanghai but 85545 sites worldwide have been identified as conducting research into it."

Answered by AI

What medical uses does SRF617 typically serve?

"SRF617 has primarily been used to treat malignant mesotheliomas, however it can be applied in the management of metastatic esophageal carcinoma, hemodialysis-related illnesses and advanced soft tissue sarcomas."

Answered by AI

How many individuals are enrolled in this research endeavor?

"At the present moment, this study has concluded its recruitment process. It was first uploaded onto clinicaltrials.gov on March 16th 2020 and underwent its last revision on November 28th of 2022. As an alternative, there are currently 2503 trials for solid tumors in advanced stages as well as 1980 studies concerning SRF617 actively looking for participants to join them."

Answered by AI

Are there still openings for individuals to take part in this research effort?

"This particular study is not currently taking on new patients, however, the trial was initially posted in March 2020 and last updated November 28th 2022. Nevertheless, there are still 4483 other trials actively searching for participants at this time according to clinicaltrials.gov"

Answered by AI

What is the geographic extent of this clinical trial?

"Presently, 10 medical centres are working to recruit patients for this clinical trial; these include Mary Crowley Cancer Research in Dallas, South Texas Accelerated Research Therapeutics in San Antonio and the University of Virginia located in Charlottesville. Additionally there are 7 other locations that require recruitment too."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of SRF617 in Patients With Advanced Solid Tumors

2020. "Study of SRF617 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04336098.