Advanced Solid CancersPhase 1NCT06710158
Study of SC-102 in Patients With Advanced Solid Tumors
A Phase 1 study testing SC-102 in people with Advanced Solid Cancers, run by Tianjin ConjuStar Biologics Co., Ltd. at 1 site in China.
Trial summary
This study will evaluate the safety, PK profile, and anti-cancer efficacy of SC-102 in subjects with advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Cancers
- What is being tested?
- SC-102
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2024to 30 Dec 2027
- 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 75 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).
- Aged 18 to 75 years at the time of signature of the ICF, without gender limitation.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score 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.
- Must be willing and able to comply with the protocol and study procedures.
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- Acceptable renal, hepatic, hematologic, and coagulation functions.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Metastatic recurrent histologically confirmed malignant solid tumors and exhausted all appropriate treatment options per local guidelines.
- Confirmation of EphA2 expression by the central laboratory prior to enrollment is not required for participants enrolled in the dose escalation study, but required for participants enrolled in the dose expansion study.
Who cannot join
- History of other malignancy(ies) within 3 years before signing the ICF, except for cured basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, papillary carcinoma of the thyroid gland, carcinoma in situ of the duct in situ, or other malignant tumors that have survived without disease for more than 5 years.
- Any anticancer treatment, including experimental treatments, within 4 weeks before the first dose of the study drug.
- Radiotherapy to >30% of the bone marrow or extensive radiotherapy within 4 weeks, or local radiotherapy (e.g., radiation therapy to the thoracic spine and ribs) within 7 days, prior to the first dose of the study drug.
- Uncontrolled central nervous system metastases.
- Preexisting treatment-related toxicity Grade ≥ 2 (except Grade 2 alopecia and hypothyroidism stable with hormone replacement therapy).
- 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 serious dermatological diseases, or having experienced serious skin toxicities during the prior anti-cancer treatment (e.g., Stevens-Johnson syndrome, toxic Epidermal Necrolysis, etc.).
- Active infection requiring systemic therapy within 14 days prior to the first dose of the study drug.
- History of thromboembolic events and bleeding disorders ≤ 3 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.
- Has received treatment within 2 weeks prior to the first dose of the study drug, or requires ongoing treatment 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Jian Zhang, MD
Hongxia Wang, MD
About this study
Official title: Phase Ⅰ Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of SC-102 in Subjects With Advanced or Metastatic Solid Tumors That Express EphA2
This study will evaluate the safety, PK profile, and anti-cancer efficacy of SC-102 in subjects with advanced solid tumors
Read the detailed description
SC-102 is a peptide drug conjugate (PDC) consisting of an EphA2-targeting peptide, a tubulin inhibitor, and a protease-hydrolysable linker.
This phase I multi-center, open-label first-in-human trial, including a dose escalation study and a dose expansion study, will evaluate SC-102 administrated once weekly or biweekly as a single agent in patients with advanced solid tumors. The dose escalation study is primarily designed to assess the safety and tolerability of SC-102 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-102.
- Conditions
- Advanced Solid Cancers
- Being tested
- SC-102
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC-102Drug
SC-102 is a peptide drug conjugate (PDC) consisting an EphA2-targeting peptide, a tubulin inhibitor, and a protease-hydrolyzable linker.
| Study group | Role | What they receive |
|---|---|---|
| SC-102 for once weekly | Experimental | Participants will receive SC-102 as a single agent once weekly on a 4-week cycle at the selected dose. Receives: Drug: SC-102 |
| SC-102 for once biweekly | Experimental | Participants will receive SC-102 as a single agent once biweekly on a 4-week cycle at the selected dose. Receives: Drug: SC-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants receiving SC-102 treatment with treatment-emergent adverse events (escalation study)
Safety reported as incidence of treatment-emergent adverse events
Measured: From Cycle 1 Day 1 (each cycle is 28 days) until 30 days post last dose
Maximum tolerated dose (MTD) by the number of participants with dose limiting toxicities from SC-102 treatment (escalation study)
Maximum Tolerated Dose (MTD)
Measured: At the end of Cycle 1 (each cycle is 28 days)
Objective response rate by RECIST 1.1 in participants with solid tumors receiving SC-102 treatment (expansion study)
Defined as the percentage of subjects who experience a best response of either complete response (CR) or partial response (PR).
Measured: From Cycle 1 Day 1 (each cycle is 28 days) until the date of first documented progression, death from any cause, start treatment of new anti-cancer agent(s), loss of follow-up, or withdrawal of consent, which ever came first, assessed up to 2 years
Secondary outcomes (7)
Maximum plasma concentration (Cmax) of SC-102 and monomethyl auristatin E (MMAE)
Plasma concentrations of SC-102 and MMAE from all participants receiving SC-102 treatment
Measured: From Cycle 1 Day 1 through the end of treatment from any cause, assessed up to 2 years
Minimum plasma concentration (Cmin) of SC-102 and monomethyl auristatin E (MMAE)
Plasma concentrations of SC-102 and MMAE from all participants receiving SC-102 treatment
Measured: From Cycle 1 Day 1 through the end of treatment from any cause, assessed up to 2 years
Area under the plasma concentration-time curve (AUC) of SC-102 and monomethyl auristatin E (MMAE)
Plasma concentrations of SC-102 and MMAE from all participants receiving SC-102 treatment
Measured: From Cycle 1 Day 1 through the end of treatment from any cause, assessed up to 2 years
Elimination half-life (t1/2) of SC-102 and monomethyl auristatin E (MMAE)
Plasma concentrations of SC-102 and MMAE from all participants receiving SC-102 treatment
Measured: From Cycle 1 Day 1 through the end of treatment from any cause, assessed up to 2 years
Number of participants positive for anti-drug antibodies (ADA)
Number of participants positive for anti-drug antibodies (ADA) from all participants receiving SC-102 treatment
Measured: From Cycle 1 Day 1 through the end of treatment from any cause, assessed up to 2 years
Duration of Response (DoR)
Defined as the time from first assessment of partial response (PR) or complete response (CR) until disease progression.
Measured: From Cycle 1 Day 1 (each cycle is 28 days) until the date of first documented progression or death from any cause, which ever came first, assessed up to 2 years
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: From Cycle 1 Day 1 (each cycle is 28 days) until the date of first documented progression, death from any cause, start treatment of new anti-cancer agent(s), loss of follow-up, or withdrawal of consent, which ever came first, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start5 Dec 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid CancersStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT06710158
- Sponsor's protocol ID
- SC-102-101
- Status last verified
- Oct 2026
- First submitted
- 21 Nov 2024
- Last updated
- 28 Oct 2026
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅰ Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of SC-102 in Subjects With Advanced or Metastatic Solid Tumors That Express EphA2
- ClinicalTrials.gov ID
- NCT06710158
- Acronym / sponsor ID
- SC-102-101
- Conditions
- Advanced Solid Cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tianjin ConjuStar Biologics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Nov 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, PK profile, and anti-cancer efficacy of SC-102 in subjects with advanced solid tumors
Detailed description
SC-102 is a peptide drug conjugate (PDC) consisting of an EphA2-targeting peptide, a tubulin inhibitor, and a protease-hydrolysable linker.
This phase I multi-center, open-label first-in-human trial, including a dose escalation study and a dose expansion study, will evaluate SC-102 administrated once weekly or biweekly as a single agent in patients with advanced solid tumors. The dose escalation study is primarily designed to assess the safety and tolerability of SC-102 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-102.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SC-102 for once weekly | Experimental | Drug: SC-102Participants will receive SC-102 as a single agent once weekly on a 4-week cycle at the selected dose. |
| SC-102 for once biweekly | Experimental | Drug: SC-102Participants will receive SC-102 as a single agent once biweekly on a 4-week cycle at the selected dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects voluntarily agree to participate in the study and sign the Informed Consent Form (ICF).
- Aged 18 to 75 years at the time of signature of the ICF, without gender limitation.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score 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 (15 listed)
- History of other malignancy(ies) within 3 years before signing the ICF, except for cured basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, papillary carcinoma of the thyroid gland, carcinoma in situ of the duct in situ, or other malignant tumors that have survived without disease for more than 5 years.
- Any anticancer treatment, including experimental treatments, within 4 weeks before the first dose of the study drug.
- Radiotherapy to >30% of the bone marrow or extensive radiotherapy within 4 weeks, or local radiotherapy (e.g., radiation therapy to the thoracic spine and ribs) within 7 days, prior to the first dose of the study drug.
- Uncontrolled central nervous system metastases.
- Preexisting treatment-related toxicity Grade ≥ 2 (except Grade 2 alopecia and hypothyroidism stable with hormone replacement therapy).
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-102SC-102 is a peptide drug conjugate (PDC) consisting an EphA2-targeting peptide, a tubulin inhibitor, and a protease-hydrolyzable linker. | Drug | SC-102 for once biweekly, SC-102 for once weekly |
Primary outcome
Number of participants receiving SC-102 treatment with treatment-emergent adverse events (escalation study)
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) until 30 days post last dose
Safety reported as incidence of treatment-emergent adverse events
Maximum tolerated dose (MTD) by the number of participants with dose limiting toxicities from SC-102 treatment (escalation study)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Maximum Tolerated Dose (MTD)
Objective response rate by RECIST 1.1 in participants with solid tumors receiving SC-102 treatment (expansion study)
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) until the date of first documented progression, death from any cause, start treatment of new anti-cancer agent(s), loss of follow-up, or withdrawal of consent, which ever came first, assessed up to 2 years
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-102 and monomethyl auristatin E (MMAE)
Time frame: From Cycle 1 Day 1 through the end of treatment from any cause, assessed up to 2 years
Minimum plasma concentration (Cmin) of SC-102 and monomethyl auristatin E (MMAE)
Time frame: From Cycle 1 Day 1 through the end of treatment from any cause, assessed up to 2 years
Area under the plasma concentration-time curve (AUC) of SC-102 and monomethyl auristatin E (MMAE)
Time frame: From Cycle 1 Day 1 through the end of treatment from any cause, assessed up to 2 years
Elimination half-life (t1/2) of SC-102 and monomethyl auristatin E (MMAE)
Time frame: From Cycle 1 Day 1 through the end of treatment from any cause, assessed up to 2 years
Number of participants positive for anti-drug antibodies (ADA)
Time frame: From Cycle 1 Day 1 through the end of treatment from any cause, assessed up to 2 years
Duration of Response (DoR)
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) until the date of first documented progression or death from any cause, which ever came first, assessed up to 2 years
Disease Control Rate (DCR)
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) until the date of first documented progression, death from any cause, start treatment of new anti-cancer agent(s), loss of follow-up, or withdrawal of consent, which ever came first, assessed up to 2 years
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 28 Oct 2026.
- 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.
1 site 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-102 in people with Advanced Solid Cancers, run by Tianjin ConjuStar Biologics Co., Ltd. at 1 site 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 10 inclusion and 15 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (086-21-33670866, wujing@conjustar.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants receiving SC-102 treatment with treatment-emergent adverse events (escalation study) (time frame: From Cycle 1 Day 1 (each cycle is 28 days) until 30 days post last dose). The study lists 3 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 28 Oct 2026.