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AMT-116 in Combination With AK112 in Patients With Lung Cancer

ConditionAdvanced Non-small Cell Lung Cancer (NSCLC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMultitude Therapeutics Inc.

About this trial

The purpose of this study is to evaluate the safety and efficacy of AMT-116 in combination with Ivonescimab (AK112) in patients with advanced non-small cell lung cancer (NSCLC). The study is divided into two parts: the part I is dose escalation and the Part Ⅱ for expansion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing and able to provide written informed consent for this trial.

At the time of screening, aged ≥18 years and ≤75 years.

Histologically or cytologically confirmed locally advanced (Stage IIIB/III C) or metastatic (Stage IV) NSCLC that is not amenable to complete surgical resection and cannot be treated with curative concurrent or sequential chemoradiotherapy (according to the 8th edition of the International Union Against Cancer and the American Joint Committee on Cancer TNM staging for lung cancer).

Stage Ib: Locally advanced/metastatic NSCLC; both subjects who have previously received systemic therapy and those who have not may be enrolled;

Disqualifiers

Histopathological evidence of small cell lung cancer.

For Cohort 1 and Cohort 2 of Phase II, patients must not have non-small cell lung cancer with known EGFR-sensitive mutations, ALK fusions, BRAF V600E mutations, ROS1 fusions, MET exon 14 skipping mutations, NTRK fusions, or RET fusions.

Prior treatment with any CD44v9-targeted therapy or an antibody-drug conjugate (ADC) based on a topoisomerase I inhibitor as the toxin.

Received systemic immunosuppressive therapy (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to the first dose.

Trial design

Design model

Sequential

Treatments tested in this trial

  • AMT-116

    Drug

    AMT-116 is an antibody Drug Conjugate (ADC)

  • AK112

    Drug

    AK112 is a PD-1/VEGF bispecific tumor immunotherapy drug

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: Phase I: Dose escalationExperimental treatment 2 interventions
Group B: Phase II: Dose ExpansionOther 2 interventions

Trial outcomes

Primary outcomes

1

Phase I: To evaluate the safety and tolerability of the combination of AMT-116 and AK112 in patients with advanced NSCLC and to determine the recommended Phase 2 dose (RP2CD)

The MTD（Maximum Tolerated Dose） and RP2CD（Recommended Phase 2 Dose） will be determined for expansion using dose limiting toxicities (DLTs) and all other available study data

Time frame
approximately 10 months
2

Phase I: Type, incidence and severity of Adverse Events,Dose Limiting Toxicities (DLTs)

Assess safety and tolerability of AMT-116 and AK112 by the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 5.0

Time frame
approximately 10 months
3

Phase II: Objective Response Rate(ORR)

To evaluate the objective response rate (ORR) \[Complete Response (CR) + Partial Response (PR)\] according to the RECIST v1.1

Time frame
approximately 12 months
4

Phase II: Type, incidence and severity of Adverse Events

Assess safety and tolerability of AMT-116 and AK112 by the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 5.0

Time frame
approximately 12 months

Secondary outcomes

1

Phase I: Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Proportion of patients achieving Complete Response (CR) or Partial Response (PR)

Time frame
approximately 10 months
2

Phase I: Disease Control Rate (DCR) according to the RECIST v1.1

Proportion of patients achieving CR, PR or Stable Disease (SD)

Time frame
approximately 10 months
3

Phase I: Progression-free Survival (PFS)Time

Time from date of start of treatment to date of the first progression or death

Time frame
approximately 10 months
4

Phase I: Levels of target expression or Tumor Infiltrating Lymphocyte in tumor tissue

To assess levels of target expression and Tumor Infiltrating Lymphocyte in tumor tissue

Time frame
approximately 10 months

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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