A Phase I/Ib Study of CHS-388 (Formerly Known as SRF388) in Patients With Advanced Solid Tumors

Study Identifier:
SRF388-101-START
CT.gov Identifier:
NCT04374877
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

Considering participating in a START clinical trial?

Get Started

Study Summary

To evaluate SRF388 in patients with advanced solid tumors.

To evaluate the safety and efficacy of SRF388 with Keytruda in patients with solid tumors.

Tumor response was assessed by RECIST v1.1. SRF388 pharmacokinetic (PK) and pharmacodynamic (PD) [phospho-STAT (pSTAT) inhibition] analyses were performed.

To establish the preliminary safety of SRF388 and to identify recommended phase 2 doses (RP2D) suitable for monotherapy and combination expansions

Tumor response was assessed by RECIST1.1.

To present antitumor activity and safety of casdozo as monotx and with pembro in NSCLC patients (pts).

Tumor response was assessed by RECIST1.1.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bowel (Colorectal)
  • Digestive organs
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Unknown: Experimental: Part A Monotherapy Dose Escalation
    • Read More
  • Drug: Unknown: Experimental: Part B CHS-388 Monotherapy Expansion
  • Drug: Unknown: Intervention:
  • Drug: Unknown: Experimental: Part C CHS-388 in Combination with Pembrolizumab
  • Drug: Unknown: Drug: Pembrolizumab
  • Drug: Unknown: Experimental: Part D CHS-388 in Combination with Toripalimab
  • Drug: Unknown: Intervetion:
  • Drug: Unknown: Drug: Toripalimab
  • Drug: Unknown:
  • Drug: Unknown: ASCO 2022:
  • Drug: Unknown: Patients will receive casdozokitug with toripalimab in NSCLC cohort.
  • Drug: Unknown: ESMO IO 2023:
  • Drug: Unknown: Patients casdozo monotherapy 10 mg/kg IV q4 wks in treatment-refractory NSCLC.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Recruiting
    Condition(s) Treated at Site
    Bowel (Colorectal)
    Digestive organs