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Unresectable Locally Advanced or Metastatic Solid TumorsPhase 1/2NCT06682611

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

A Phase 1/2 study testing SYHA1813, SG001 and HB1801 in people with Unresectable Locally Advanced or Metastatic Solid Tumors, run by Shanghai Runshi Pharmaceutical Technology Co., Ltd.

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
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SYHA1813, SG001 and HB1801
Could I receive a placebo?
No, everyone receives an active treatment
How many people
380 participants
Where
No sites listed yet
Study dates
13 Nov 2024to 13 Nov 2027
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

  • 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.

Who cannot join

  • 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;
Show all 17Show fewer
  • 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.;

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information contact

86-0311-69085587

ctr-contact@cspc.cn

About this study

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.

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.

Read the detailed description

In the safety run-in stage, the "3+3" design is used to evaluate the tolerability and safety of different dose levels combined with different regimens, and the observation period of DLT is set as the first treatment cycle. After 3 DLT-evaluable participants at each dose level completed the DLT observation period, the safety of the dose level is evaluated by an SMC consisting of the investigator and the sponsor's medical monitor. Cohorts 1-4 enter the cohort expansion stage after determining the SYHA1813 dose regimen during the safety run-in stage. Cohorts 5-8 enter the cohort expansion stage directly. In the expansion stage, cohorts 1-6 are single-arm studies, the primary endpoint is ORR as evaluated by investigator according to RECIST 1.1. Cohorts 7-8 are randomized controlled studies, the primary endpoint is PFS as evaluated by investigator according to RECIST 1.1.

Being tested
SYHA1813, SG001, HB1801, Carboplatin, Cisplatin

What participants receive

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

  • SYHA1813Drug

    In accordance with the protocol

  • SG001Drug

    In accordance with the protocol

  • HB1801Drug

    In accordance with the protocol

  • CarboplatinDrug

    In accordance with the protocol

  • CisplatinDrug

    In accordance with the protocol

  • PaclitaxelDrug

    In accordance with the protocol

  • EtoposideDrug

    In accordance with the protocol

  • EverolimusDrug

    In accordance with the protocol

  • RegorafenibDrug

    In accordance with the protocol

Study groups in NCT06682611
Study groupRoleWhat they receive
SYHA1813 single agent or in combination with different regimensExperimentalCohorts 1-4 are SYHA1813 combined with different regimens. Cohorts 5-8 are SYHA1813 monotherapy.
Receives: Drug: SYHA1813; Drug: Everolimus; Drug: Regorafenib
Control groupActive comparatorThe cohort 7 control group is Everolimus. The cohort 8 control group is Regorafenib.
Receives: Drug: SYHA1813; Drug: SG001; Drug: HB1801; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Etoposide; Drug: Everolimus; Drug: Regorafenib

What is being measured

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

  1. DLT

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

    Measured: Up to approximately 2years

  2. Frequency and severity of TEAE and SAE

    Safety run-in stage

    Measured: Up to approximately 2years

  3. ORR

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

    Measured: Up to approximately 2 years

  4. PFS

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

    Measured: Up to approximately 2years

Secondary outcomes (6)

  1. OS

    Overall survival

    Measured: Up to approximately 2years

  2. DoR

    Duration of response

    Measured: Up to approximately 2years

  3. DCR

    Disease control rate

    Measured: Up to approximately 2 years

  4. Frequency and severity of TEAE and SAE

    Safety

    Measured: Up to approximately 2 years

  5. Plasma Concentration

    Concentration of SYHA1813/SG001/HB1801 in serum

    Measured: Up to approximately 2 years

  6. Immunogenicity

    Incidence of SG001 Anti-drug antibody (ADA) and neutralizing antibody (Nab) (if applicable)

    Measured: Up to approximately 2 years

Timeline

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

  1. First posted12 Nov 2024
  2. Study start13 Nov 2024 (estimated)
  3. Primary completion13 Nov 2026 (estimated)
  4. Study completion13 Nov 2027 (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
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06682611
Sponsor's protocol ID
SYHA1814-005
Status last verified
Nov 2024
First submitted
8 Nov 2024
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SYHA1813, SG001 and HB1801 in people with Unresectable Locally Advanced or Metastatic Solid Tumors, run by Shanghai Runshi Pharmaceutical Technology Co., Ltd.

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 8 inclusion and 17 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

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 Clinical Trials Information (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: Up to approximately 2years). The study lists 4 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 NCT06682611.

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 12 Nov 2024.

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