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

ConditionUnresectable Locally Advanced or Metastatic Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Runshi Pharmaceutical Technology Co., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged >= 18 years;

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SYHA1813

    Drug

    In accordance with the protocol

  • SG001

    Drug

    In accordance with the protocol

  • HB1801

    Drug

    In accordance with the protocol

  • Carboplatin

    Drug

    In accordance with the protocol

  • Cisplatin

    Drug

    In accordance with the protocol

  • Paclitaxel

    Drug

    In accordance with the protocol

  • Etoposide

    Drug

    In accordance with the protocol

  • Everolimus

    Drug

    In accordance with the protocol

  • Regorafenib

    Drug

    In accordance with the protocol

Treatment groups

380 Participants
are divided into 2 treatment groups
Group A: SYHA1813 single agent or in combination with different regimensExperimental treatment 3 interventions
Group B: Control groupActive comparator 9 interventions

Trial outcomes

Primary outcomes

1

DLT

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

Time frame
Up to approximately 2years
2

Frequency and severity of TEAE and SAE

Safety run-in stage

Time frame
Up to approximately 2years
3

ORR

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

Time frame
Up to approximately 2 years
4

PFS

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

Time frame
Up to approximately 2years

Secondary outcomes

1

OS

Overall survival

Time frame
Up to approximately 2years
2

DoR

Duration of response

Time frame
Up to approximately 2years
3

DCR

Disease control rate

Time frame
Up to approximately 2 years
4

Frequency and severity of TEAE and SAE

Safety

Time frame
Up to approximately 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Runshi Pharmaceutical Technology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: