A Phase Ⅰ Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of SC-101 in Subjects With Advanced or Metastatic Solid Tumors That Express Nectin-4

Tianjin ConjuStar Biologics Co., Ltd.5 sites in 1 country100 target enrollmentFebruary 2, 2024

ConditionsAdvanced Solid Tumor

InterventionsSC-101

DrugsSC-101

Overview

Phase: Phase 1
Intervention: SC-101
Conditions: Advanced Solid Tumor
Sponsor: Tianjin ConjuStar Biologics Co., Ltd.
Enrollment: 100
Locations: 5
Primary Endpoint: Incidence of adverse events (dose escalation phase)
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the safety, pharmacokinetics, and anti-cancer efficacy of SC-101 in subjects with advanced or metastatic solid tumors.

Detailed Description

This study is the first-in-human (FIH), multi-center, open-label trial of SC-101, including the dose escalation and expansion phases. The dose escalation study is primarily designed to assess the safety and tolerability of SC-101 and to determine the recommended dose(s) for the dose expansion study. The dose expansion study is designed with the primary objective of evaluating the clinical activity of SC-101 in patients with metastatic urothelial carcinoma or other solid tumors that express Nectin-4.

Registry

clinicaltrials.gov

Start Date

February 2, 2024

End Date

September 1, 2026

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tianjin ConjuStar Biologics Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects voluntarily agree to participate in the study and sign the Informed Consent Form (ICF).
•18 to 80 years of age at the time of signature of the ICF, without gender limitation.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
•Life expectancy of ≥ 3 months as assessed by the investigator.
•Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the study.
•Understand study requirements, and willing and able to comply with arrangements of study and follow-up procedures.
•Adequate Bone Marrow Reserve and Organ Functions.
•Subjects must have measurable disease according to RECIST (version 1.1).
•Histologically or cytologically confirmed advanced malignant solid tumors.
•For non-urothelial carcinoma patients enrolled in the dose expansion study: Subjects must have a positive expression of Nectin-4 in their tumor samples as confirmed by the central laboratory.

Exclusion Criteria

•History of other malignancy(ies) within 3 years before signing the ICF, except for non-melanoma skin cancer, cervical carcinoma in situ, or other malignant tumors that are considered to have been cured.
•Any anticancer therapy, including any investigational drug, within 2 weeks before the first dose of the study drug.
•Uncontrolled central nervous system metastases.
•Prior treatment with Nectin-4-targeting anti-cancer therapy.
•Preexisting treatment-related toxicity Grade ≥ 2 (except alopecia).
•Preexisting Grade ≥ 2 (as per CTCAE v5.0) sensory or motor neuropathy.
•Major surgery within 4 weeks prior to the first dose of the study drug.
•History of interstitial lung disease (ILD), preexisting ILD, or the suspected ILD that cannot be ruled out by imaging examination at screening.
•Preexisting active keratitis or corneal ulcerations.
•Preexisting serious dermatological diseases, or having experienced serious skin toxicities during the prior anti-cancer treatment (e.g., Stevens-Johnson syndrome, toxic Epidermal Necrolysis, etc.).

Arms & Interventions

SC-101

Intervention: SC-101

Outcomes

Primary Outcomes

Incidence of adverse events (dose escalation phase)

Time Frame: Up to 30 days after the last dose of study drug

Objective response rate (dose expansion phase)

Time Frame: Every 8 weeks (± 7 days)

Defined as the percentage of subjects who experience a best response of either complete response (CR) or partial response (PR).

Secondary Outcomes

Maximum plasma concentration (Cmax) of SC-101 and monomethyl auristatin E (MMAE) when given as monotherapy(From Cycle 1 Day 1 through end of treatment (EOT))
Minimum plasma concentration (Cmin) of SC-101 and monomethyl auristatin E (MMAE) when given as monotherapy(From Cycle 1 Day 1 through end of treatment (EOT))
Area under the plasma concentration-time curve (AUC) of SC-101 and monomethyl auristatin E (MMAE) when given as monotherapy(From Cycle 1 Day 1 through end of treatment (EOT))
Elimination half-life (t1/2) of SC-101 and monomethyl auristatin E (MMAE) when given as monotherapy(From Cycle 1 Day 1 through end of treatment (EOT))
Number of participants positive for anti-drug antibodies (ADA)(From Cycle 1 Day 1 through end of treatment (EOT))
Duration of Response (DoR)(Every 8 weeks (± 7 days))
Disease Control Rate (DCR)(Every 8 weeks (± 7 days))