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Advanced Solid TumorPhase 1/2NCT06970132

Study of SY-5933 Plus CT-707 in Advanced Solid Tumors With KRAS p.G12C Mutation

A Phase 1/2 study testing SY-5933 and CT-707 in people with Advanced Solid Tumor, run by Shouyao Holdings (Beijing) Co. LTD at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This Phase Ib/II, open-label, single-arm study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of SY-5933 tablets combined with CT-707 tablets in patients with advanced solid tumors harboring the KRAS p.G12C mutation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
SY-5933 and CT-707
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteChina
Study dates
Jun 2025to Dec 2028
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following criteria to be eligible for enrollment in this study:
  • Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor.
  • Age ≥ 18 years at the time of informed consent, regardless of gender.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Life expectancy of at least 12 weeks.
  • Presence of at least one extracranial target lesion (as defined by RECIST v1.1). Lesions previously treated with radiation therapy may only be considered target lesions if there is clear progression following radiation therapy.
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  • KRAS (G12C) mutation positive. For the Phase Ib dose-escalation phase, participants must have previously undergone standard treatment for advanced tumors. In the Phase II cohorts: Cohort 1 (NSCLC), Cohort 2 (colorectal cancer), Cohort 3 (pancreatic cancer), and Cohort 4 (other solid tumors). In the Phase Ib expansion phase, except for NSCLC, patients with other tumor types must have previously undergone standard treatment for advanced tumors. For Cohort 2-4 of Phase II, initial enrollment will prioritize patients who have received prior standard treatment, but frontline patients may be considered if sufficient efficacy and safety data are collected during Phase Ib or the Phase II study, following review by the Safety Monitoring Committee (SMC) to assess the benefit-risk ratio.
  • Adequate organ function as defined below:
  • Liver function:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× upper limit of normal (ULN), or ≤ 5× ULN if liver metastasis is present.
  • Total bilirubin (TBIL) ≤ 1.5× ULN, or ≤ 3× ULN and direct bilirubin (DBIL) ≤ 1.5× ULN if liver metastasis or Gilbert's syndrome is present.
  • Bone marrow function (No blood products, hematopoietic growth factors, or other treatments for hematological abnormalities within 7 days prior to dosing):
  • Absolute neutrophil count (ANC) ≥ 1.5×10^9/L. Platelet count (PLT) ≥ 75×10^9/L. Hemoglobin (Hb) ≥ 90 g/L.
  • Renal function:
  • Creatinine clearance ≥ 50 mL/min.
  • Coagulation function:
  • Prothrombin time (PT) or International Normalized Ratio (INR) ≤ 1.5× ULN (except for subjects on anticoagulation therapy).
  • For women of childbearing potential, a negative serum pregnancy test must be obtained within 7 days prior to the first dose. Male and female participants of childbearing potential must agree to use adequate contraception or remain abstinent during the study and for at least 3 months after the last dose of investigational drug.
  • Able to swallow oral medications and comply with the study protocol and follow-up requirements.

Who cannot join

  • Patients meeting any of the following criteria will be excluded from this study:
  • For patients in the Ib expansion cohort and Phase II, the presence of known major oncogenic driver alterations other than KRAS G12C mutation, such as EGFR, ALK, ROS1, RET, NTRK, KRAS G12D, etc. (Patients with co-mutations may be considered for enrollment after discussion with the investigator).
  • Prior treatment with a KRAS p.G12C inhibitor.
  • Receipt of chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other anti-tumor therapies within 3 weeks prior to the first dose of study drug, except for the following:
  • Nitrosoureas or mitomycin C administered within 6 weeks prior to the first dose;
  • Oral fluoropyrimidines and small molecule targeted agents administered within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose.
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  • Receipt of any investigational agents or therapies not yet approved for marketing within 4 weeks prior to the first dose.
  • Underwent major surgery involving major organs (excluding needle biopsy) or experienced significant trauma within 4 weeks prior to the first dose.
  • Adverse events from prior anti-cancer therapies have not recovered to Grade ≤1 as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 (except for toxicities assessed by the investigator as posing no safety risk, such as alopecia and Grade 2 peripheral neuropathy).
  • Presence of spinal cord compression, leptomeningeal metastasis, symptomatic brain metastases, or CNS disease requiring escalating doses of corticosteroids. Subjects with previously treated and stable CNS metastases are eligible if neurologic function is stable, no new neurologic deficits are observed on clinical examination, and there is no evidence of radiographic progression for at least 4 weeks prior to the first dose. If corticosteroids are required for CNS metastases, the dose must have been stable for at least 2 weeks prior to study entry.
  • Active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose.
  • Active hepatitis infection (defined as HBsAg positive with HBV-DNA ≥2000 IU/mL; or HCV antibody positive with HCV-RNA ≥1000 IU/mL), HIV infection, or active syphilis (both non-treponemal and treponemal tests positive) that remains uncontrolled despite appropriate treatment, as assessed by the investigator.
  • Presence of other severe pulmonary conditions requiring systemic treatment, such as active tuberculosis, interstitial lung disease, etc., that may, in the opinion of the investigator, affect study results or place the subject at unacceptable risk.
  • History or presence of severe cardiovascular or cerebrovascular diseases/abnormalities, including but not limited to:
  • Significant arrhythmias or conduction abnormalities requiring clinical intervention (e.g., clinically significant ventricular arrhythmias, Grade II-III atrioventricular block);
  • Resting QTc interval corrected by Fridericia's formula (QTcF) >470 msec for females or >450 msec for males (Subjects with suspected drug-induced QTcF prolongation may be enrolled after investigator assessment and correction with medication if deemed safe);
  • Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade ≥3 cardiovascular or cerebrovascular events occurring within 6 months prior to the first dose;
  • New York Heart Association (NYHA) Class ≥II heart failure or left ventricular ejection fraction (LVEF) <50%;
  • Uncontrolled hypertension despite optimal medical therapy, defined as an average systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg based on at least three repeated measurements at intervals of at least 10 minutes.
  • Use of strong CYP3A inhibitors or inducers within 1 week or 5 half-lives (whichever is longer) prior to the first dose or anticipated use during the study period (Refer to Section 15.6 of the clinical trial protocol for details).
  • History of malignancies other than the tumor type under investigation, except for: Malignancies that have been cured and have not recurred within 2 years prior to enrollment; Completely resected basal cell or squamous cell carcinoma of the skin; Completely resected carcinoma in situ of any type.
  • Presence of significant gastrointestinal diseases that may affect drug absorption, including but not limited to active ulcerative colitis, Crohn's disease, peptic ulcer disease, or prior major gastrointestinal surgery significantly affecting absorption, as assessed by the investigator.
  • History of hypersensitivity to any components or excipients of the study drug.
  • Presence of poorly controlled pleural effusion, ascites, or pericardial effusion after intervention (defined as rapid re-accumulation or symptomatic recurrence within 2 weeks post-drainage requiring further intervention).
  • Poorly controlled diabetes mellitus [defined as fasting blood glucose ≥10 mmol/L and/or HbA1c ≥8%], uncontrolled symptomatic hyperthyroidism or hypothyroidism, or uncontrolled symptomatic hypercalcemia or hypocalcemia.
  • Coagulation disorders or bleeding diathesis, including but not limited to: History of arterial or venous thromboembolism within 6 months prior to the first dose (e.g., myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other serious thromboembolic events); History of life-threatening bleeding events (requiring transfusion, surgical or local intervention, or sustained medical treatment); Tumor invasion of major blood vessels posing a high risk of bleeding, as assessed by the investigator.
  • Pregnancy or lactation.
  • Any condition that, in the opinion of the investigator, may increase the risk associated with study drug administration, interfere with study results interpretation, affect subject compliance, or otherwise make the subject unsuitable for participation in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yinghui Sun, PhD contact

86-10-88858616

yhsun@centaurusbio.com

China1 site

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021

    Yuankai Shi, MD, 86-10-87788293, syuankai@cicams.ac.cn

Other trials in China

About this study

Official title: A Phase Ib/II, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SY-5933 Tablets in Combination With CT-707 Tablets in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation

This Phase Ib/II, open-label, single-arm study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of SY-5933 tablets combined with CT-707 tablets in patients with advanced solid tumors harboring the KRAS p.G12C mutation. The Phase Ib includes a dose-escalation phase to determine the optimal dosing regimen based on safety and pharmacokinetic data. In Phase II, four cohorts will be enrolled: advanced KRAS p.G12C mutated non-small cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer, and other solid tumors.

Read the detailed description

This is an open-label, single-arm Phase Ib/II trial to assess the combination of SY-5933 and CT-707 in KRAS p.G12C mutated advanced solid tumors. In Phase Ib, six patients will receive 800 mg of SY-5933 and 600 mg of CT-707 once daily (QD) in a dose-escalation design, with dose adjustments based on safety, pharmacokinetic and efficacy data. The Ib expansion phase will further investigate the most promising dose/frequency combinations. In Phase II, four cohorts will be treated: advanced NSCLC, colorectal cancer, pancreatic cancer, and other solid tumors with KRAS p.G12Cmutation. Efficacy will be evaluated through interim analyses based on objective response rate. Patients will be treated until disease progression, unacceptable toxicity, death, or study completion.

Being tested
SY-5933, CT-707
Keywords
KRAS p.G12C Mutation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SY-5933Drug

    Also called SY-5933 tablet

    KRAS p.G12C inhibitor

  • CT-707Drug

    Also called CT-707 tablet, SY-707 tablet, Conteltinib

    Focal Adhesion Kinase (FAK) inhibitor

Study groups in NCT06970132
Study groupRoleWhat they receive
Phase Ib/II study of SY-5933 and CT-707 combinationExperimentalIn Phase Ib, six KRAS p.G12C mutation-positive patients will first receive 800 mg QD SY-5933 and 600 mg QD CT-707 for dose escalation. The dose of CT-707 may be adjusted based on safety, pharmacokinetic and efficacy data. 1-2 regimens will be selected for an expansion phase. The Phase II study will treat KRAS p.G12C mutation-positive patients with SY-5933 and CT-707 across four tumor types (NSCLC, colorectal cancer, pancreatic cancer, and other solid tumors) until disease progression or intolerable toxicity.
Receives: Drug: SY-5933; Drug: CT-707

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs) and serious adverse events (SAEs) in KRAS p.G12C Mutant Advanced Solid Tumors in Phase Ib

    Evaluate the safety and tolerability of SY-5933 combined with CT-707

    Measured: Up to 24 months

  2. Dose-limiting toxicity (DLT) of SY-5933 combined with CT-707 in KRAS p.G12C Mutant Advanced Solid Tumors in Phase Ib

    To determine the recommended phase 2 dose (RP2D)

    Measured: From first dose to end of DLT observation period (approximately 28 days)

  3. Objective response rate (ORR) of SY-5933 combined with CT-707 in KRAS p.G12C Mutant Advanced Solid Tumors in Phase II

    Evaluate the ORR based on RECIST v1.1 criteria to assess the preliminary efficacy of SY-5933 combined with CT-707 in patients with advanced solid tumors harboring KRAS p.G12C mutation

    Measured: Up to 24 months

Secondary outcomes (9)

  1. Pharmacokinetics (Cmax)

    Defined as maximum observed plasma concentration of investigational drugs

    Measured: rotocol-defined time points during Cycles 1 and 2 of treatment (each cycle is 28 days)

  2. Pharmacokinetics (Tmax)

    Defined as time to maximum plasma concentration of investigational drugs

    Measured: rotocol-defined time points during Cycles 1 and 2 of treatment (each cycle is 28 days)

  3. Pharmacokinetics (AUC0-t)

    Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration of investigational drugs

    Measured: rotocol-defined time points during Cycles 1 and 2 of treatment (each cycle is 28 days)

  4. Pharmacokinetics (t½)

    Defined as the apparent plasma terminal phase disposition half-life of investigational drugs

    Measured: rotocol-defined time points during Cycles 1 and 2 of treatment (each cycle is 28 days)

  5. ORR of SY-5933 combined with CT-707 in KRAS p.G12C mutant advanced solid tumors in Phase Ib

    Evaluate the ORR based on RECIST v1.1 criteria to assess the preliminary efficacy of SY-5933 combined with CT-707 in patients with advanced solid tumors harboring KRAS p.G12C mutation

    Measured: Up to 24 months

  6. Incidence of adverse events (AEs) and serious adverse events (SAEs) in KRAS p.G12C mutant advanced solid tumors in Phase II

    Evaluate the safety and tolerability of SY-5933 combined with CT-707

    Measured: Up to 24 months

  7. Disease control rate (DCR) in Phase Ib and Phase II

    Evaluate the DCR based on RECIST v1.1 criteria to assess the preliminary efficacy of SY-5933 combined with CT-707 in patients with advanced solid tumors harboring KRAS p.G12C mutation

    Measured: Up to 24 months

  8. Duration of response (DoR) in Phase Ib and Phase II

    Evaluate the DoR based on RECIST v1.1 criteria to assess the preliminary efficacy of SY-5933 combined with CT-707 in patients with advanced solid tumors harboring KRAS p.G12C mutation

    Measured: Up to 24 months

  9. Progression-free survival (PFS) in Phase Ib and Phase II

    Evaluate the PFS based on RECIST v1.1 criteria to assess the preliminary efficacy of SY-5933 combined with CT-707 in patients with advanced solid tumors harboring KRAS p.G12C mutation

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06970132
Sponsor's protocol ID
SY-5933-II-01
Status last verified
May 2025
First submitted
27 Apr 2025
Last updated
14 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SY-5933 and CT-707 in people with Advanced Solid Tumor, run by Shouyao Holdings (Beijing) 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 19 inclusion and 28 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: opening soon, as of the sponsor's last update on 14 May 2025. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Yinghui Sun, PhD (86-10-88858616, yhsun@centaurusbio.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 (AEs) and serious adverse events (SAEs) in KRAS p.G12C Mutant Advanced Solid Tumors in Phase Ib (time frame: Up to 24 months). 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?

On the ClinicalTrials.gov record for NCT06970132.

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 14 May 2025.

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