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Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

ConditionsEwing SarcomaColorectal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12-85
SponsorInhibrx Biosciences, Inc

About this trial

This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females aged ≥12 to less than 85 years for Ewing sarcoma and 18 to less than 85 years of age for other tumors.

Histologically confirmed Ewing sarcoma with a classical fusion: Patients with locally advanced or metastatic, unresectable, relapsed, or refractory disease who have received at least 1 but no more than 2 prior lines of systemic treatment with a preferred first line chemotherapy regimens.

Colorectal adenocarcinoma: Patients who have failed 1 (one) prior line of systemic therapy that did not include irinotecan.

Colorectal adenocarcinoma: Patients who have failed 2 but no more than 3 prior lines of systemic therapy and are FTD/TPI-naïve.

Disqualifiers

Prior treatment with or exposure to DR5 agonists.

Receipt of any anticancer therapy (including investigational agents) within 4 weeks or within 5 half-lives prior to the first dose of study treatment. Exceptions per protocol.

Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.

Receipt of radiotherapy within 4 weeks prior to the first dose of study treatment, and liver-directed within 12 months prior to the first dose of study drug.

Trial design

Design model

Sequential

Treatments tested in this trial

  • INBRX-109

    Drug

    Tetravalent DR5 Agonist Antibody

  • Irinotecan

    Drug

    Chemotherapy

  • Temozolomide

    Drug

    Chemotherapy

  • carboplatin

    Drug

    chemotherapy

  • pemetrexed

    Drug

    chemotherapy

  • Leucovorin

    Drug

    chemotherapy

  • Fluorouracil

    Drug

    chemotherapy

  • Bevacizumab

    Drug

    targeted therapy

  • Trifluridine + Tipiracil

    Drug

    chemotherapy

Treatment groups

411 Participants
are divided into 14 treatment groups

14

Treatment groups

See each treatment group below.

Group A: Dose Escalation (Complete)Experimental treatment 1 intervention
Group B: Expansion Malignant Pleural Mesothelioma (Complete)Experimental treatment 1 intervention
Group C: Expansion Gastric Adenocarcinoma (Complete)Experimental treatment 1 intervention
Group D: Expansion Colorectal Adenocarcinoma (Complete)Experimental treatment 1 intervention
Group E: Expansion Sarcomas (Complete)Experimental treatment 1 intervention
Group F: Combination Expansion Malignant Pleural Mesothelioma (Complete)Experimental treatment 3 interventions
Group G: Combination Expansion Pancreatic Adenocarcinoma (Complete)Experimental treatment 4 interventions
Group H: Combination Expansion Adult Ewing SarcomaExperimental treatment 3 interventions
Group I: Combination Expansion Colorectal Adenocarcinoma (Complete)Experimental treatment 4 interventions
Group J: Expansion Solid Tumors (Complete)Experimental treatment 1 intervention
Group K: Combination Expansion SDH-deficient solid tumors or GIST (Complete)Experimental treatment 2 interventions
Group L: Combination Expansion Colorectal Adenocarcinoma patients with FOLFIRI plus bevacizumabExperimental treatment 5 interventions
Group M: Combination Expansion Colorectal Adenocarcinoma with FTD/TPI plus bevacizumabExperimental treatment 3 interventions
Group N: Combination Expansion Adolescent Ewing SarcomaExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Frequency and severity of adverse events of INBRX-109

Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

Time frame
Up to 8 years
2

Evaluating Tumor Response for colorectal cancers and Ewing sarcoma

Evaluating how the tumor responds to treatment by measuring the number of patients with colorectal cancer and Ewing sarcoma that experience tumor shrinkage and for how long.

Time frame
Up to 8 years

Secondary outcomes

1

Immunogenicity of INBRX-109

Frequency of ant-drug antibodies (ADA) against INBRX-109 will be determined.

Time frame
Up to 8 years
2

Characterize the pharmacokinetics of INBRX-109 as a single agent, and of INBRX-109 in combination with distinct chemotherapies.

A measurement which indicates how the body processes INBRX-109 and how long it stays in the system.

Time frame
Up to 8 years
3

Median progression-free survival for colorectal adenocarcinoma and Ewing sarcoma.

Progression-free survival is defined as the time from start of study treatment until documented disease progression or death.

Time frame
Up to 8 years

Other outcomes

1

Anti-tumor activity of INBRX-109

Tumor response will be determined by RECISTv1.1.

Time frame
Up to 8 years
2

Potential predictive response biomarkers

Evaluate the relationship between potential predictive response biomarkers and efficacy of INBRX-109

Time frame
Up to 8 years

Sponsors and contacts

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

Inhibrx Biosciences, Inc

Lead sponsor

Source ClinicalTrials.gov
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