Advanced Solid TumorPhase 1NCT06220838
Study SC-101 in Subjects With Advanced Malignancies
A Phase 1 study testing SC-101 in people with Advanced Solid Tumor, run by Tianjin ConjuStar Biologics Co., Ltd. at 5 sites in China.
Trial summary
This study will evaluate the safety, pharmacokinetics, and anti-cancer efficacy of SC-101 in subjects with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- SC-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesChina
- Study dates
- 2 Feb 2024to Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
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- 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.
Who cannot join
- 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.
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- 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:
- Serious cardiac arrhythmias or conduction abnormalities, such as ventricular arrhythmia require treatment, and grade 2 or 3 atrioventricular block.
- QTc prolongation to >450 milliseconds (ms) in males and >470 ms in females based on ECG.
- 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.
- New myocardial infarction or unstable angina within 6 months before the first dose of the study drug.
- Uncontrolled hypertension.
- Require ongoing therapy with a medication that is a strong inhibitor or inducer of the cytochrome P450 3A4 (CYP3A4) enzymes.
- Known sensitivity to any of the ingredients of the investigational product.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo, Dr., guoj307@126.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
Yu Xie, MD
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Hongqian Guo, MD
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Hongxia Wang, MD
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Xin Yao, MD
About this study
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
This study will evaluate the safety, pharmacokinetics, and anti-cancer efficacy of SC-101 in subjects with advanced or metastatic solid tumors.
Read the 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- SC-101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC-101Drug
All subjects will receive a single intravenous (IV) infusion of SC-101 once weekly.
| Study group | Role | What they receive |
|---|---|---|
| SC-101 | Experimental | Not described Receives: Drug: SC-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (dose escalation phase)
Measured: 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).
Measured: Every 8 weeks (± 7 days)
Secondary outcomes (7)
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
Measured: 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
Plasma concentrations of SC-101 and MMAE from all participants taking SC-101 alone
Measured: 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
Plasma concentrations of SC-101 and MMAE from all participants taking SC-101 alone
Measured: 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
Plasma concentrations of SC-101 and MMAE from all participants taking SC-101 alone
Measured: From Cycle 1 Day 1 through end of treatment (EOT)
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
Measured: From Cycle 1 Day 1 through end of treatment (EOT)
Duration of Response (DoR)
Defined as the time from first assessment of partial response (PR) or complete response (CR) until disease progression.
Measured: Every 8 weeks (± 7 days)
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).
Measured: Every 8 weeks (± 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start2 Feb 2024
- Primary completionMar 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin ConjuStar Biologics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220838
- Sponsor's protocol ID
- SC-101-101
- Status last verified
- Jul 2025
- First submitted
- 12 Jan 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06220838
- Acronym / sponsor ID
- SC-101-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tianjin ConjuStar Biologics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SC-101 | Experimental | Drug: SC-101 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 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.
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SC-101All subjects will receive a single intravenous (IV) infusion of SC-101 once weekly. | Drug | SC-101 |
Primary outcome
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).
7 secondary outcomes
Maximum plasma concentration (Cmax) of SC-101 and monomethyl auristatin E (MMAE) when given as monotherapy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From Cycle 1 Day 1 through end of treatment (EOT)
Number of participants positive for anti-drug antibodies (ADA)
Time frame: From Cycle 1 Day 1 through end of treatment (EOT)
Duration of Response (DoR)
Time frame: Every 8 weeks (± 7 days)
Disease Control Rate (DCR)
Time frame: Every 8 weeks (± 7 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SC-101 in people with Advanced Solid Tumor, run by Tianjin ConjuStar Biologics Co., Ltd. at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Wu (86-21-33670866, wujing@conjustar.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (dose escalation phase) (time frame: Up to 30 days after the last dose of study drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.