Health TrialsbyHealthPanel

A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combinations in Advanced Solid Tumors

ConditionAdvanced Solid Tumor Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHC Biopharma Inc.

About this trial

Phase Ib study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced gastrointestinal cancer and determine the recommended dose for subsequent studies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Fully understand this trial and voluntarily sign the informed consent form. 2. For locally recurrent or metastatic unresectable advanced solid tumors that are diagnosed by histological or cytopathological pathology and cannot be radically treated with radiotherapy, the range-finding stage does not limit specific tumor types and previous treatment conditions.

Disqualifiers

1.Imaging shows that the tumor invades great vessels or is not clearly demarcated from blood vessels.

Trial design

Design model

Sequential

Treatments tested in this trial

  • HC010

    Drug

    HC010 once every 3 weeks (Q3W) by intravenous drip

  • Paclitaxel

    Drug

    the combination chemotherapy regimens are all commonly used in clinical practice

  • Oxaliplatin

    Drug

    the combination chemotherapy regimens are all commonly used in clinical practice

  • Capecitabine

    Drug

    the combination chemotherapy regimens are all commonly used in clinical practice

  • HC006

    Drug

    HC006 once every 3 weeks (Q3W) by intravenous drip

Treatment groups

331 Participants
are divided into 3 treatment groups
Group A: HC010 + PaclitaxelExperimental treatment 2 interventions
Group B: HC010 + Oxaliplatin + CapecitabineExperimental treatment 3 interventions
Group C: HC010 + HC006Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicities (DLTs)

Time frame
From first dose to 21 days

Secondary outcomes

1

Objective response rate (ORR) as assessed by the investigator according to RECIST 1.1 criteria

Time frame
Up to approximately 2 years
2

Disease control rate (DCR) as assessed by the investigator according to RECIST 1.1 criteria

Time frame
Up to approximately 2 years
3

Maximum concentration (Cmax) of HC010

Time frame
Up to approximately 2 years
4

Number of positive cases of HC010 anti-drug antibody (ADA)

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

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

HC Biopharma Inc.

Lead sponsor

Source ClinicalTrials.gov
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