Study SC-101 in Subjects With Advanced Malignancies

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06220838
• Other study ID #: SC-101-101
• Status: Recruiting
• Phase: Phase 1
• Start date: February 27, 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Tianjin ConjuStar Biologics Co., Ltd.
• Contact: Yongchao Li, Dr.
• Phone: 86-21-33670866
• Email: liyongchao[@]conjustar.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study is the first-in-human (FIH) trial of SC-101, including the dose escalation and expansion phases.

The dose escalation and dose expansion studies are both open-label, multi-center SC-101 single-agent dose escalation studies, in which eligible participants with advanced or metastatic solid tumors will be enrolled. Subjects will receive SC-101 monotherapy weekly in a 28-day cycle until disease progression, intolerable toxicity, withdrawal consent, and other conditions leading to treatment discontinuation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Subjects voluntarily agree to participate in the study and sign the Informed Consent Form (ICF).

2. 18 to 80 years of age at the time of signature of the ICF, without gender limitation.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

4. Life expectancy of = 3 months as assessed by the investigator.

5. Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the study.

6. Understand study requirements, and willing and able to comply with arrangements of study and follow-up procedures.

7. Adequate Bone Marrow Reserve and Organ Functions.

8. Subjects must have measurable disease according to RECIST (version 1.1).

9. Histologically or cytologically confirmed advanced malignant solid tumors.

10. 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.

11. Subjects are willing to follow study procedures.

Exclusion Criteria:

1. 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.

2. Any anticancer therapy, including any investigational drug, within 2 weeks before the first dose of the study drug.

3. Uncontrolled central nervous system metastases.

4. Prior treatment with Nectin-4-targeting anti-cancer therapy.

5. Preexisting treatment-related toxicity Grade = 2 (except alopecia).

6. Preexisting Grade = 2 (as per CTCAE v5.0) sensory or motor neuropathy.

7. Major surgery within 4 weeks prior to the first dose of the study drug.

8. History of interstitial lung disease (ILD), preexisting ILD, or the suspected ILD that cannot be ruled out by imaging examination at screening.

9. Preexisting active keratitis or corneal ulcerations.

10. 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.).

11. 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.

12. History of uncontrolled diabetes mellitus.

13. 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.

14. Positive results of virus serology tests.

15. History of serious cardiovascular and cerebrovascular diseases, including but not limited to:

1. Serious cardiac arrhythmias or conduction abnormalities, such as ventricular arrhythmia require treatment, and grade 2 or 3 atrioventricular block.

2. QTc prolongation to >450 milliseconds (ms) in males and >470 ms in females based on ECG.

3. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or transient ischemic attack (TIA) within 6 months prior to the first dose of the study drug.

4. New myocardial infarction or unstable angina within 6 months before the first dose of the study drug.

5. Uncontrolled hypertension.

16. Require ongoing therapy with a medication that is a strong inhibitor or inducer of the cytochrome P450 3A4 (CYP3A4) enzymes.

17. Known sensitivity to any of the ingredients of the investigational product.

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin ConjuStar Biologics Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (dose escalation phase)		Up to 30 days after the last dose of study drug
Primary	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	Maximum plasma concentration (Cmax) of SC-101 and monomethyl auristatin E (MMAE) when given as monotherapy	Plasma concentrations of SC-101 and MMAE from all participants taking SC-101 alone	From Cycle 1 Day 1 through end of treatment (EOT)
Secondary	Minimum plasma concentration (Cmin) of SC-101 and monomethyl auristatin E (MMAE) when given as monotherapy	Plasma concentrations of SC-101 and MMAE from all participants taking SC-101 alone	From Cycle 1 Day 1 through end of treatment (EOT)
Secondary	Area under the plasma concentration-time curve (AUC) of SC-101 and monomethyl auristatin E (MMAE) when given as monotherapy	Plasma concentrations of SC-101 and MMAE from all participants taking SC-101 alone	From Cycle 1 Day 1 through end of treatment (EOT)
Secondary	Elimination half-life (t1/2) of SC-101 and monomethyl auristatin E (MMAE) when given as monotherapy	Plasma concentrations of SC-101 and MMAE from all participants taking SC-101 alone	From Cycle 1 Day 1 through end of treatment (EOT)
Secondary	Number of participants positive for anti-drug antibodies (ADA)	Number of participants positive for anti-drug antibodies (ADA) from all participants receiving SC-101 monotherapy	From Cycle 1 Day 1 through end of treatment (EOT)
Secondary	Duration of Response (DoR)	Defined as the time from first assessment of partial response (PR) or complete response (CR) until disease progression.	Every 8 weeks (± 7 days)
Secondary	Disease Control Rate (DCR)	Defined as the percentage of subjects who experience a best response of either complete response (CR), partial response (PR) or stable disease (SD).	Every 8 weeks (± 7 days)