Study SC-101 in Subjects With Advanced Malignancies

NCT06220838 | Recruiting Phase 1

• 1 other identifier: SC-101-101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events (dose escalation phase)

  Up to 30 days after the last dose of study drug

• Objective response rate (dose expansion phase)

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

  Every 8 weeks (± 7 days)

Secondary Outcomes (7)

• 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)

Study Arms (1)

SC-101

EXPERIMENTAL

Drug: SC-101

Interventions

SC-101 DRUG

All subjects will receive a single intravenous (IV) infusion of SC-101 once weekly.

SC-101

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects voluntarily agree to participate in the study and sign the Informed Consent Form (ICF).
• 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 1.
• 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.
• Subjects are willing to follow study procedures.

You may not qualify if:

• 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.).
• Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of first dose of study drug, or fever within 14 days prior to the first dose of the study drug.
• History of uncontrolled diabetes mellitus.
• History of thromboembolic events and bleeding disorders ≤ 6 months (e.g.,deep vein thrombosis (DVT) or pulmonary embolism ( PE)) prior to the first dose of the study drug.
• Positive results of virus serology tests.
• History of serious cardiovascular and cerebrovascular diseases, including but not limited to:

Sponsors & Collaborators

• Tianjin ConjuStar Biologics Co., Ltd.: lead

Study Sites (5)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Central Study Contacts

Jing Wu

CONTACT

86-21-33670866; wujing@conjustar.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 24, 2024
• Study Start: February 2, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)