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

NCT06682611 | Not Yet Recruiting Phase 1

• 1 other identifier: SYHA1814-005
• Study Type: interventional
• Target: 380
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Unresectable Locally Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (4)

• DLT

  Safety run-in stage，Dose-limiting toxicity (DLT) will be assessed according to NCI-CTCAE v5.0.

  Up to approximately 2years

• Frequency and severity of TEAE and SAE

  Safety run-in stage

  Up to approximately 2years

• ORR

  Cohorts 1-6, Objective response rate (ORR) as evaluated by Investigator (RECIST1.1)

  Up to approximately 2 years

• PFS

  Cohorts 7-8, Progression-free survival (PFS) as evaluated by Investigator (RECIST1.1)

  Up to approximately 2years

Secondary Outcomes (6)

• OS

  Up to approximately 2years

• DoR

  Up to approximately 2years

• DCR

  Up to approximately 2 years

• Frequency and severity of TEAE and SAE

  Up to approximately 2 years

• Plasma Concentration

  Up to approximately 2 years

Study Arms (2)

SYHA1813 single agent or in combination with different regimens

EXPERIMENTAL

Cohorts 1-4 are SYHA1813 combined with different regimens. Cohorts 5-8 are SYHA1813 monotherapy.

Drug: SYHA1813; Drug: Everolimus; Drug: Regorafenib

Control group

ACTIVE COMPARATOR

The cohort 7 control group is Everolimus. The cohort 8 control group is Regorafenib.

Drug: SYHA1813; Drug: SG001; Drug: HB1801; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Etoposide; Drug: Everolimus; Drug: Regorafenib

Interventions

SYHA1813 DRUG

In accordance with the protocol

Control group; SYHA1813 single agent or in combination with different regimens

SG001 DRUG

In accordance with the protocol

Control group

HB1801 DRUG

In accordance with the protocol

Control group

Carboplatin DRUG

In accordance with the protocol

Control group

Cisplatin DRUG

In accordance with the protocol

Control group

Paclitaxel DRUG

In accordance with the protocol

Control group

Etoposide DRUG

In accordance with the protocol

Control group

Everolimus DRUG

In accordance with the protocol

Control group; SYHA1813 single agent or in combination with different regimens

Regorafenib DRUG

In accordance with the protocol

Control group; SYHA1813 single agent or in combination with different regimens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Shanghai Runshi Pharmaceutical Technology Co., Ltd: lead

MeSH Terms

Interventions

Carboplatin; Cisplatin; Paclitaxel; Etoposide; Everolimus; regorafenib

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Sirolimus; Macrolides; Lactones

Central Study Contacts

Clinical Trials Information

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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. In the expansion stage, cohorts 1-6 are single-arm studies, cohorts 7-8 are randomized controlled studies.

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: November 13, 2024
• Primary Completion (Estimated): November 13, 2026
• Study Completion (Estimated): November 13, 2027
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share