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A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer

ConditionColorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMultitude Therapeutics Inc.

About this trial

This study is an open, multi-center, phase II study, aiming to evaluate the safety, tolerability and efficacy of AMT-676 combined with 5-fluorouracil, leucovorin, bevacizumab (or cetuximab) in participants with advanced colorectal cancer, and to assess the PK(Pharmacokinetic) characteristics and immunogenicity of AMT-676.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements

Patients with pathologically confirmed, unresectable advanced colorectal adenocarcinoma

Patients must have at least one measurable lesion as per RECIST version 1.1

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Disqualifiers

Prior treatment with any same target

Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP

Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1

Major surgery within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention, or a surgery is planned to be conducted within the expected participation period of the trial or within 4 weeks after the last administration of the drug

Trial design

Design model

Parallel

Treatments tested in this trial

  • AMT-676

    Drug

    Patients will get different dose levels treatment of AMT-676. AMT-676 will be Administered as an intravenous (IV) infusion every 2 weeks (Q2W) .

  • 5-FU

    Drug

    5-FU 400 mg/m\^2 IV bolus on day 1, followed by 1200 mg/m\^2/day x 2 days (total 2400 mg/m\^2 over 46-48 hours) IV continuous infusion, q2w

  • Leucovorin

    Drug

    Leucovorin 400 mg/m\^2 IV day 1, q2w

  • Bevacizumab

    Drug

    Bevacizumab 5 mg/kg IV, day 1

  • Cetuximab

    Drug

    Cetuximab 500 mg/m\^2 IV over 2 hours, day 1, q2w

  • Irinotecan

    Drug

    Irinotecan 180 mg/m\^2 IV, day 1

  • Oxaliplatin

    Drug

    Oxaliplatin 85 mg/m\^2 IV, day 1

Treatment groups

180 Participants
are divided into 4 treatment groups
Group A: AMT-676(dose level 1)+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable)Experimental treatment 5 interventions
Group B: AMT-676(dose level 2)+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable)Experimental treatment 5 interventions
Group C: oxaliplatin/irinotecan+5-FU+ leucovorin +bevacizumab (or cetuximab)Experimental treatment 6 interventions
Group D: AMT-676+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable)+OxaliplatinExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

AE & SAE

Type, incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time frame
30 days after the last treatment
2

MTD

Maximum Tolerated Dose will be determined by DLTs

Time frame
28 days after first dose
3

DLTs

Incidence of dose limiting toxicities

Time frame
28 days after first dose
4

ORR

Overall response rate

Time frame
through study completion, an average of 18 months

Secondary outcomes

1

Cmax

maximum concentration of the ADC, total antibody and free payload

Time frame
From first dose to end of treatment, an average of 1 year
2

Ctrough

predose concentration of the ADC, total antibody and free payload

Time frame
From first dose to end of treatment, an average of 1 year
3

AUC

Area Under the Curve of the ADC, total antibody and free payload

Time frame
From first dose to end of treatment, an average of 1 year
4

Specification of anti-drug antibodies

Time frame
From first dose to end of treatment, an average of 1 year

Other outcomes

Sponsors and contacts

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

Multitude Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov
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