> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/safety-and-efficacy-of-syha1813-single-agent-or-in-eba0bc4d-ef9c-427e-87a9-372a312c3461
> Record changed: 2026-10-13

# Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.

NCT06682611

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

Phase

Phase 1/Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

Recruitment status

Not yet recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

Participants

380

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

Lead sponsor

Shanghai Runshi Pharmaceutical Technology Co., Ltd

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

Start date

2024-11-13

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

## Title and summary

**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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**Short title**

Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

## Status and phase

**Control arm**

Active comparator

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**Recruitment status**

Not yet recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**Phase**

Phase 1/Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

## Dates

**Completion date**

2027-11-13

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**First posted**

2024-11-12

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**Registry last updated**

2024-11-12

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**Primary completion date**

2026-11-13

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**Start date**

2024-11-13

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

## Size and sites

**Participants**

380

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**Planned participants**

380

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**Protocol amendments**

0

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**Lead sponsor**

Shanghai Runshi Pharmaceutical Technology Co., Ltd

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

## Identifiers

**Registry ID**

NCT06682611

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**ClinicalTrials.gov ID**

NCT06682611

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

No masking

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

## Outcomes

### Primary outcomes

1. DLT  
Timeframe: Up to approximately 2years  
Safety run-in stage，Dose-limiting toxicity (DLT) will be assessed according to NCI-CTCAE v5.0.
2. Frequency and severity of TEAE and SAE  
Timeframe: Up to approximately 2years  
Safety run-in stage
3. ORR  
Timeframe: Up to approximately 2 years  
Cohorts 1-6, Objective response rate (ORR) as evaluated by Investigator (RECIST1.1)
4. PFS  
Timeframe: Up to approximately 2years  
Cohorts 7-8, Progression-free survival (PFS) as evaluated by Investigator (RECIST1.1)

### Secondary outcomes

1. OS  
Timeframe: Up to approximately 2years  
Overall survival
2. DoR  
Timeframe: Up to approximately 2years  
Duration of response
3. DCR  
Timeframe: Up to approximately 2 years  
Disease control rate
4. Frequency and severity of TEAE and SAE  
Timeframe: Up to approximately 2 years  
Safety
5. Plasma Concentration  
Timeframe: Up to approximately 2 years  
Concentration of SYHA1813/SG001/HB1801 in serum
6. Immunogenicity  
Timeframe: Up to approximately 2 years  
Incidence of SG001 Anti-drug antibody (ADA) and neutralizing antibody (Nab) (if applicable)

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Healthy volunteers**

No

### Inclusion criteria

1. Aged >= 18 years;
2. Unresectable locally advanced or metastatic solid tumors confirmed by histology or cytology:
3. There is at least one measurable lesion in the baseline period (RECIST1.1);
4. ECOG PS of 0-1;
5. The expected survival time is >=3 months;
6. 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
7. 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.

### Exclusion criteria

1. Patients who are known or suspected to be allergic to the test drug or its components;
2. 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);
3. 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;
4. Active leptomeningeal disease or CNS metastases that are not well controlled;
5. 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
6. Patients with evidence of bleeding tendency or medical history within 28 days;
7. Patients have risk factors for intestinal obstruction or intestinal perforation;
8. The subject has poorly healed wounds, ulcers or fractures;
9. Urine protein ≥ 2+, and 24-hour urine protein quantitative ≥ 1.0g/24h;
10. Patients have large pleural effusions, pericardial effusions, or abdominopelvic effusions;
11. 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;
12. Has a history of active tuberculosis;
13. History of interstitial lung disease (except for radiotherapy-induced focal interstitial pneumonia), noninfectious pneumonitis requiring glucocorticoid therapy;
14. Received immunosuppressants such as PD-1 or PD-L1 inhibitors in the recurrent or metastatic phase (only for Cohort 1);
15. Prior treatment with a VEGFR-TKI inhibitor or other anti-angiogenic agent (except for Cohort 5,7,8);
16. Pregnant or lactating women;
17. 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.;

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682611)

## Related records

### Drugs (7)

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### Lead sponsors (1)

- [Shanghai Runshi Pharmaceutical Technology Co., Ltd](https://trialight.com/data/company/shanghai-runshi-pharmaceutical-technology-co-ltd-41a52856-d0b5-4d9c-ab40-7e1ddd0e700f.md)

### Targets (35)

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- [BRAF](https://trialight.com/data/target/braf-d7fd2910-24ea-5f05-9b83-3cd3e5d8bbdd.md)
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- [FKBP1A](https://trialight.com/data/target/fkbp1a-caa2dbe9-c679-5ba2-9bd0-18b303620352.md)
- [FLT1](https://trialight.com/data/target/flt1-2cfcec95-3fff-5be9-8423-701697547fa0.md)
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- [RAF1](https://trialight.com/data/target/raf1-0ec15c38-cbfa-5a16-b6ab-f12c16356dd7.md)
- [RET](https://trialight.com/data/target/ret-74a9a0b3-98e1-5324-8125-26e0d68c7b16.md)
- [TEK](https://trialight.com/data/target/tek-8c4a1834-7f6d-5bd8-856d-23e03f1ae791.md)
- [TOP2A](https://trialight.com/data/target/top2a-ee962484-09ab-5c5a-8b7b-1242173c1ca8.md)

---

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