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A Phase Ib/II Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.

ConditionCRC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company

About this trial

This is a multicenter, open-label Phase Ib/II clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and efficacy of the HS-20110 combination therapies in Patients with Advanced Colorectal Cancer. "Rolling 6" design would be used to conduct dose escalation part of this study. This study consists of phase Ib and phase II. After RP2D was determined in phase Ib, then a phase II study will be conducted to further evaluate the efficacy, safety, tolerability, and PK of the HS-20110 combination therapies in Patients with mCRC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females, aged ≥ 18 years.

Participants with pathologically confirmed advanced Colorectal Cancer.

Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.1.

MSI was tested to be non-MSI-H, and without BRAF V600E mutation.

Disqualifiers

Anti-tumor drugs within 14 days prior to the first dose of study treatment; any other IMPs or macromolecular anti-tumor drugs within 28 days prior to the first dose of study treatment.

Local radiotherapy within 2 weeks prior to the first dose of study treatment; irradiation of more than 30% of bone marrow or extensive radiotherapy within 4 weeks prior to the first dose of study treatment.

Major surgery within 4 weeks prior to the first dose of study treatment.

Participants previously treated with drugs that are moderate to strong inhibitors or moderate to strong inducers of cytochrome P450 (CYP) 3A4, strong inhibitors or strong inducers of CYP2D6, P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) or drugs with a narrow therapeutic range that are sensitive substrates of P-gp or BCRP within 7 days prior to the first dose of the IMP. Participants who need to receive these drugs during the study period should also be excluded.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Cohort 1: HS-20110+ Bevacizumab+5-FU/leucovorin

    Drug

    HS-20110 for IV infusion of various dosage in combination with Bevacizumab+5-FU/leucovorin administered in Q2W doseing cycles

  • Cohort 2: HS-20110+Bevacizumab+Oxaliplatin+5-FU/leucovorin

    Drug

    HS-20110 for IV infusion of various dosage in combination with Bevacizumab+Oxaliplatin+5-FU/leucovorin administered in Q2W doseing cycles

  • Cohort 3: HS-20110+Bevacizumab+Oxaliplatin+Capecitabine

    Drug

    HS-20110 for IV infusion of various dosage in combination with Bevacizumab+Oxaliplatin+Capecitabine administered in Q3W doseing cycles

Treatment groups

502 Participants
are divided into 3 treatment groups
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum tolerated dose (MTD) or maximum applicable dose (MAD)

Time frame
From day 1 to one month after the last dose in Phase 1b
2

Recommended phase 2 dose (RP2D)

Time frame
From day 1 to one month after the last dose in Phase 1b
3

Objective response rate (ORR) as per RECIST v1.1

Time frame
From day 1 to 3 months after the last patient enrolled in Phase 2

Secondary outcomes

1

Incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to dose modification or permanent discontinuation, and specific laboratory abnormalities

Time frame
From the first dose until 90 days after the last dose
2

Objective response rate (ORR)

Time frame
From first dose until 3 years after last dose
3

Incidence of anti-HS-20110 antibody (ADA)

Time frame
From the first dose until 90 days after the last dose
4

Drug concentrations of the three components of HS-20110 (including antibody-drug conjugates, total antibody, and payload)

Time frame
From the first dose until 90 days after the last dose

Other outcomes

Sponsors and contacts

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

Hansoh BioMedical R&D Company

Lead sponsor

Source ClinicalTrials.gov
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