Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.
- Summary
- This is an open-label, multi-center, multi-cohort, phase Ib/II clinical trial, divided into 8 cohorts according to tumor types. Cohorts 1-4 are SYHA1813 combined with different regimens, including safety run-in stage and cohort expansion stage. Cohorts 5-8 are SYHA1813 monotherapy and only include the expansion cohorts. The primary objective was to evaluate the safety and efficacy of SYHA1813 single agent or in combination with different regimens in unresectable locally advanced or metastatic solid tumors.
- Short title
- Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.
- Official title
- An, Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 1/Phase 2
- Study type
- Interventional
- Completion date
- 2027-11-13
- First posted
- 2024-11-12
- Registry last updated
- 2024-11-12
- Primary completion date
- 2026-11-13
- Start date
- 2024-11-13
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Shanghai Runshi Pharmaceutical Technology Co., Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06682611
- ClinicalTrials.gov ID
- NCT06682611
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
DLT
Timeframe: Up to approximately 2years
Safety run-in stage，Dose-limiting toxicity (DLT) will be assessed according to NCI-CTCAE v5.0.
Frequency and severity of TEAE and SAE
Timeframe: Up to approximately 2years
Safety run-in stage
ORR
Timeframe: Up to approximately 2 years
Cohorts 1-6, Objective response rate (ORR) as evaluated by Investigator (RECIST1.1)
PFS
Timeframe: Up to approximately 2years
Cohorts 7-8, Progression-free survival (PFS) as evaluated by Investigator (RECIST1.1)
OS
Timeframe: Up to approximately 2years
Overall survival
DoR
Timeframe: Up to approximately 2years
Duration of response
DCR
Timeframe: Up to approximately 2 years
Disease control rate
Frequency and severity of TEAE and SAE
Timeframe: Up to approximately 2 years
Safety
Plasma Concentration
Timeframe: Up to approximately 2 years
Concentration of SYHA1813/SG001/HB1801 in serum
Immunogenicity
Timeframe: Up to approximately 2 years
Incidence of SG001 Anti-drug antibody (ADA) and neutralizing antibody (Nab) (if applicable)
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
-
Aged >= 18 years;
-
Unresectable locally advanced or metastatic solid tumors confirmed by histology or cytology:
-
There is at least one measurable lesion in the baseline period (RECIST1.1);
-
ECOG PS of 0-1;
-
The expected survival time is >=3 months;
-
The organ function level and related laboratory indicators must meet the following requirements (No blood transfusion or hematopoietic stimulating factor therapy received within 14 days prior to the first medication (queue 1 to 6)/prior to randomization (queue 7 and queue 8):
ANC≥1.5×10^9/L； PLT≥100×10^9/L（Liver cancer patients PLT≥75×10^9/L）； Hb≥90 g/L； TBIL≤1.5×ULN，and for Gilbert's syndrome, liver cancer or liver metastasis patients TBIL≤3×ULN； ALT和AST≤2.5×ULN，for liver cancer or liver metastasis patients ≤5×ULN； Child-Pugh Grade A (only applicable to queue 8)； ALB≥30 g/L； Cr≤1.5×ULN，IF Cr>1.5×ULN，Ccr≥60 mL/min（Cockcroft-Gault）is required； APTT and INR≤1.5×ULN
-
The subjects must agree to take medically approved contraceptive measures for at least 6 months from the beginning of the study to the last dose of drug.
- Patients who are known or suspected to be allergic to the test drug or its components;
- Excluding the disease studied in this trial, there are other primary malignant tumors that have progressed or require treatment within the past 3 years prior to screening (except for effectively controlled skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer or cured breast carcinoma in situ);
- The toxicity of previous anti-tumor treatments has not recovered (≤grode 1), except for hair loss and other adverse reactions judged by the investigator that do not affect the safety of the study medication;
- Active leptomeningeal disease or CNS metastases that are not well controlled;
- Uncontrollable active infections occurred within 14 days prior to the first medication (queue 1 to 6)/prior to randomization (queue 7 and queue 8), requiring systemic treatment with intravenous antibiotic infusion
- Patients with evidence of bleeding tendency or medical history within 28 days;
- Patients have risk factors for intestinal obstruction or intestinal perforation;
- The subject has poorly healed wounds, ulcers or fractures;
- Urine protein ≥ 2+, and 24-hour urine protein quantitative ≥ 1.0g/24h;
- Patients have large pleural effusions, pericardial effusions, or abdominopelvic effusions;
- Human immunodeficiency virus (HIV) antibody positive; active hepatitis C, with antibody positive and HCV RNA test positive; active hepatitis B, with HBsAg positive, and HBV-DNA value>500 IU/ml or 2500 copies/mL;
- Has a history of active tuberculosis;
- History of interstitial lung disease (except for radiotherapy-induced focal interstitial pneumonia), noninfectious pneumonitis requiring glucocorticoid therapy;
- Received immunosuppressants such as PD-1 or PD-L1 inhibitors in the recurrent or metastatic phase (only for Cohort 1);
- Prior treatment with a VEGFR-TKI inhibitor or other anti-angiogenic agent (except for Cohort 5,7,8);
- Pregnant or lactating women;
- Participants who may have poor compliance as judged by the investigator, such as a clear history of neurological or psychiatric disorders (including epilepsy or dementia), current psychiatric disorders, psychotropic drug abuse, etc.;