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Study of SRF114 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT05635643
Recruitment Status : Recruiting
First Posted : December 2, 2022
Last Update Posted : January 4, 2023
Sponsor:
Information provided by (Responsible Party):
Surface Oncology

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Head and Neck Squamous Cell Carcinoma Drug: SRF114 Phase 1 Phase 2

Detailed Description:

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 advanced solid tumors, that will be conducted in 2 parts:

  • Part A: SRF114 monotherapy dose-escalation portion of the study will enroll approximately 30 patients with advanced solid tumors.
  • Part B: SRF114 monotherapy expansion cohort(s) will evaluate the safety, efficacy, tolerability, pharmacokinetics, and pharmacodynamics of SRF114 in indication specific cohort(s). Up to approximately 40 patients will be enrolled.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of SRF114 in Patients With Advanced Solid Tumors
Actual Study Start Date : December 15, 2022
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part A Monotherapy Dose Escalation
The Part A monotherapy dose escalation portion of the study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SRF114 as monotherapy in up to 30 patients with advanced solid tumors, to determine the recommended phase 2 dose (RP2D) .
Drug: SRF114
SRF114

Experimental: Part B Monotherapy Expansion
The Part B monotherapy expansion will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SRF114 monotherapy at the recommended phase 2 dose (RP2D) in up to 40 patients with Head and Neck Squamous Cell Carcinoma (HNSCC).
Drug: SRF114
SRF114




Primary Outcome Measures :
  1. [Part A] Rate of Dose Limiting Toxicity (DLT) [ Time Frame: Assessed during first 21 days of treatment ]
    Evaluation of rate of DLT of SRF114 as a monotherapy.

  2. [Part B] Confirmed objective response rate (ORR) [ Time Frame: Up to 24 months ]
    Confirmed objective response rate (ORR) based on RECIST v1.1


Secondary Outcome Measures :
  1. [Part A, Part B] Summary of adverse events (AEs) based on treatment emergent AEs (TEAEs) [ Time Frame: Up to 24 months ]
    Safety and tolerability of SRF114 will be assessed by summarizing adverse events (AEs) and will be based on treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher.

  2. Anti-drug Antibodies (ADAs) to SRF114 [ Time Frame: Up to 24 monthss ]
    Serum will be collected and assessed for the development of ADAs to SRF114

  3. [Part A, Part B] Pharmacokinetics (PK) of SRF114 [ Time Frame: Up to 24 months ]
    Serum concentrations of SRF114 will be collected and analyzed to evaluate the PK of SRF114

  4. [Part A] Confirmed objective response rate (ORR) [ Time Frame: Up to 24 months ]
    Confirmed objective response rate (ORR) based on RECIST v1.1

  5. [Part A, Part B] Duration of response (DoR) [ Time Frame: Up to 24 months ]
    Duration of response (DoR) based on RECIST v1.1. DoR is defined as the time from the first documented response (CR or PR) to documented disease progression as determined by RECIST v1.1 or death.

  6. [Part A, Part B] Disease control rate (DCR) [ Time Frame: Up to 24 months ]
    Disease control rate (DCR) based on RECIST v1.1. DCR is defined as the percentage of patients with CR, partial PR, or stable disease lasting a minimum of 12 weeks.

  7. [Part A, Part B] Progression-free survival (PFS) [ Time Frame: Up to 24 months ]
    Progression-free survival (PFS) based on RECIST v1.1. PFS is defined as the time from the first treatment on study with study drug to documented disease progression as determined by RECIST v1.1 or death.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria - Parts A and B

  • Patients must be ≥ 18 years of age.
  • For Part A only, locally advanced or metastatic (Stage IV) solid tumor that has progressed during or after standard therapy and for whom no available therapies are appropriate (based on the judgment of the Investigator).
  • At least 1 measurable lesion per RECIST 1.1.
  • Lesions previously treated with radiation or other forms of locoregional therapy must show radiographic evidence of disease progression to be used as a target lesion.
  • Washout period from the last dose of previous anticancer therapy (chemotherapy, biologic, or other investigational agent) to the initiation of study drug must be > 5 times the half-life of the agent or > 21 days (whichever is shorter).
  • Resolution of non-immune-related AEs secondary to prior anticancer therapy (excluding alopecia and peripheral neuropathy) to ≤ Grade 1 per NCI-CTCAE version 5.0 or higher, and complete resolution of immune-related AEs secondary to prior checkpoint inhibitor therapy.
  • Serum creatinine clearance ≥ 30 mL/min per Cockcroft-Gault formula.
  • Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN if elevated because of Gilbert's syndrome and ≤ 2 × ULN for patients with hepatocellular carcinoma [HCC] or patients with known liver metastases).
  • Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) < 2.5 × ULN or < 5 × ULN for patients with known liver metastases.
  • Adequate hematologic function, defined as absolute neutrophil count ≥ 1.0 × 109/L, hemoglobin ≥ 9.0 g/dL, and platelet count ≥ 75 × 109/L.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Ejection fraction ≥ 50%, as measured by echocardiogram, multigated acquisition scan, nuclear stress test, or equivalent modality.
  • Willingness of male and female patients who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control for the duration of the study treatment period, including 30 days after the last dose of SRF114; male patients must refrain from donating sperm during this period. Sexually active men, and women using oral contraceptive pills, should also use barrier contraception. Azoospermic male patients and WCBP who are continuously not heterosexually active are exempt from contraceptive requirements.

Additional Inclusion Criteria - Part B Only

  • Histologically or cytologically confirmed advanced or metastatic HNSCC that has progressed during or after a platinum-based chemotherapy and/or a programmed cell death receptor (PD)-1 or PD ligand 1 (PD-L1) targeting agent (separately or in combination therapy).
  • Metastatic or locoregionally recurrent HNSCC malignancy that is incurable by surgery or radiotherapy.
  • Part B patients who agree to provide optional tumor biopsies must have tumor tissue that is accessible for pretreatment and on-treatment tumor biopsy in the opinion of the Investigator and be willing and consent to undergo pretreatment and on-treatment biopsies per protocol.

Key Exclusion Criteria - Parts A and B

  • Previously received an anti-CCR8 antibody or anti-CCR8 targeted therapy.
  • History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody therapy or any excipient in the study drugs.
  • Major surgery within 4 weeks prior to Screening.
  • Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes, symptomatic fistula) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the risk to the patient associated with his or her participation in the study.

Additional Exclusion Criteria - Part B Only

  • Received > 4 prior systemic regimens for advanced/metastatic disease.
  • Nasopharyngeal carcinoma or nasal cavity malignancies other than HNSCC (eg, adenocarcinoma and variants, neuroendocrine tumors, mucosal melanoma).
  • Receiving chronic anti-coagulation therapy (eg, warfarin, enoxaparin) that cannot be safely discontinued temporarily for the required biopsies (only for patients who provide tumor biopsies).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05635643


Contacts
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Contact: Kristin Brosofsky 617-865-3260 kbrosofsky@surfaceoncology.com

Locations
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United States, Texas
START- San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Amita Patnaik         
Sponsors and Collaborators
Surface Oncology
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Responsible Party: Surface Oncology
ClinicalTrials.gov Identifier: NCT05635643    
Other Study ID Numbers: SRF114-101
First Posted: December 2, 2022    Key Record Dates
Last Update Posted: January 4, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Surface Oncology:
metastatic solid tumors
advanced solid tumors
Phase 1
SRF114
CCR8
safety
efficacy
immunotherapy
cancer
immuno-oncology
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Neoplasms
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Head and Neck Neoplasms
Neoplasms by Site