Part B Monotherapy Expansion for Head and Neck Squamous Cell Carcinoma (HNSCC)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Head and Neck Squamous Cell Carcinoma (HNSCC)+1 MoreSRF114 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase 1/2, open-label, first-in-human, dose-escalation and expansion study of SRF114, a monoclonal antibody that targets CCR8, as a monotherapy in patients with solid tumors.

Eligible Conditions
  • Advanced Solid Tumors
  • Head and Neck Squamous Cell Carcinoma (HNSCC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Up to 24 months

Day 21
[Part A] Rate of Dose Limiting Toxicity (DLT)
Up to 24 months
[Part A, Part B] Disease control rate (DCR)
[Part A, Part B] Duration of response (DoR)
[Part A, Part B] Pharmacokinetics (PK) of SRF114
[Part A, Part B] Progression-free survival (PFS)
[Part A, Part B] Summary of adverse events (AEs) based on treatment emergent AEs (TEAEs)
[Part A] Confirmed objective response rate (ORR)
[Part B] Confirmed objective response rate (ORR)
Up to 24 monthss
Anti-drug Antibodies (ADAs) to SRF114

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Part B Monotherapy Expansion
1 of 2
Part A Monotherapy Dose Escalation
1 of 2

Experimental Treatment

70 Total Participants · 2 Treatment Groups

Primary Treatment: Part B Monotherapy Expansion · No Placebo Group · Phase 1 & 2

Part B Monotherapy Expansion
Drug
Experimental Group · 1 Intervention: SRF114 · Intervention Types: Drug
Part A Monotherapy Dose Escalation
Drug
Experimental Group · 1 Intervention: SRF114 · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months

Who is running the clinical trial?

Surface OncologyLead Sponsor
5 Previous Clinical Trials
719 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have solid tumor that has progressed during or after standard therapy and for whom no available therapies are appropriate.
You have received a previous dose of an investigational agent and are initiating a new dose
You are eligible if you are ≥ 18 years of age.
The target lesion must show radiographic evidence of disease progression to be used as a target lesion.
You have a serum creatinine clearance of 30 mL/min or greater.