Study of INBRX-109 in Conventional Chondrosarcoma (ChonDRAgon)

• ClinicalTrials.gov Identifier: NCT04950075
• Recruitment Status: Recruiting
• First Posted: July 6, 2021
• Last Update Posted: May 15, 2023
• Sponsor: Inhibrx, Inc.
• Information provided by (Responsible Party): Inhibrx, Inc.

Tracking Information

• First Submitted Date: June 14, 2021
• First Posted Date: July 6, 2021
• Last Update Posted Date: May 15, 2023
• Actual Study Start Date: September 23, 2021
• Estimated Primary Completion Date: February 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 30, 2021)

Progression-free survival per RECISTv1.1 comparing INBRX-109 and placebo [ Time Frame: 3 years ]

Progression-free survival per RECISTv1.1 will be determined.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 10, 2023)

• Overall survival of patients comparing INBRX-109 and placebo [ Time Frame: 3 years ]
  Overall Survival in the ITT population
• Overall response rate (in percent), duration of response (in time) and disease control rate (in percent) [ Time Frame: 3 years ]
  Tumor response will be determined by RECISTv1.1.
• PFS per RECISTv1.1 by Investigator assessment [ Time Frame: 3 years ]
  PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo.
• Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo [ Time Frame: 3 years ]
  Quality of life will be determined.
• DCR per RECISTv1.1 by real-time IRR [ Time Frame: 3 years ]
  measured by DCR per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo
• DOR per RECISTv1.1 by real-time IRR [ Time Frame: 3 years ]
  evaluate duration of response (DOR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo
• To evaluate the safety and tolerability of INBRX-109 [ Time Frame: 3 years ]
  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.
• Characterize the pharmacokinetics of INBRX-109. [ Time Frame: 3 years ]
  AUC0-inf, AUC0-last, AUC0-21d, Cmax, Ctrough, Tmax will be estimated using a standard non- Sponsor: Inhibrx, Inc. Version 5.0 (Amendment 4) Protocol Number: Ph2 INBRX-109 SA CS 28-Feb-2023 Page 41 of 113 CONFIDENTIAL Objective Endpoint compartmental method as the data allow. Other PK parameters (λz, t1/2, Vd, CL, and accumulation ratios RCmax, RCtrough)
• Immunogenicity of INBRX-109 [ Time Frame: 3 years ]
  Frequency of anti-drug antibodies against INBRX-109 will be determined.

Original Secondary Outcome Measures (submitted: June 30, 2021)

• Overall survival of patients comparing INBRX-109 and placebo [ Time Frame: 3 years ]
  Overall survival will be determined.
• Overall response rate (in percent), duration of response (in time) and disease control rate (in percent) [ Time Frame: 3 years ]
  Tumor response will be determined by RECISTv1.1.
• Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo [ Time Frame: 3 years ]
  Quality of life will be determined.
• Incidence and grades of treatment-emergent adverse events including serious adverse events [ Time Frame: 3 years ]
  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.
• Immunogenicity of INBRX-109 [ Time Frame: 3 years ]
  Frequency of anti-drug antibodies against INBRX-109 will be determined.
• Area under the curve of INBRX-109 [ Time Frame: 3 years ]
  The area under the curve of INBRX-109 will be determined.
• Peak serum concentration (Cmax) of INBRX-109 [ Time Frame: 3 years ]
  The peak serum concentration (Cmax) of INBRX-109 will be determined.
• Trough serum concentration (Ctrough) of INBRX-109 [ Time Frame: 3 years ]
  The trough serum concentration (Ctrough) of INBRX-109 will be determined.
• Time to maximum concentration (Tmax) of INBRX-109 [ Time Frame: 3 years ]
  The time to maximum concentration (Tmax) of INBRX-109 will be determined.

Current Other Pre-specified Outcome Measures (submitted: May 10, 2023)

• Evaluate Quality of Life [ Time Frame: 3 years ]
  QoL per EORTC QLQ-C30, EQ-5D-5L, PGI-C, PGI-S
• Potential predictive response biomarkers [ Time Frame: 3 years ]
  Evaluate the relationship between potential predictive response biomarkers and efficacy of INBRX-109
• PFS per RECISTv1.1 by Investigator assessment [ Time Frame: 3 years ]
  evaluate the anticancer efficacy of INBRX-109 as measured by PFS (by Investigator assessment) for crossover population after treatment with INBRX-109
• ORR per RECISTv1.1 by Investigator assessment [ Time Frame: 3 years ]
  evaluate the anticancer efficacy of INBRX-109 as measured by ORR (by Investigator assessment) for crossover population after treatment with INBRX-109

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of INBRX-109 in Conventional Chondrosarcoma
• Official Title: A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma
• Brief Summary: Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
• Detailed Description: This is a randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. INBRX-109 is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

INBRX-109 and placebo arms are in parallel. Patients on placebo are allowed to cross-over to open-label INBRX-109 at time of disease progression.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

• Condition: Conventional Chondrosarcoma

Intervention

• Drug: INBRX-109
  Tetravalent DR5 Agonist Antibody
• Drug: Placebo
  Placebo

Study Arms

• Experimental: INBRX-109
  IV every three weeks
  Intervention: Drug: INBRX-109
• Placebo Comparator: Placebo
  IV every three weeks
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 30, 2021): 201
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2024
• Estimated Primary Completion Date: February 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.
2. Measurable disease by RECISTv1.1. Note: Tumor lesions located in a previously irradiated (or other locally treated) area will be considered measurable, provided there has been clear imaging-based progression of the lesions since the time of treatment.
3. Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study.
4. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
6. Estimated life expectancy of at least 12 weeks.
7. Availability of archival tissue or fresh cancer biopsy are mandatory.

Exclusion Criteria:

1. Any prior exposure to DR5 agonists.
2. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
3. Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.
4. Prior or concurrent malignancies. Exception: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments.
5. Chronic liver diseases. Exception: Patients with fatty liver disease are acceptable as long as adequate hepatic function as defined in the inclusion/exclusion criteria is confirmed.
6. Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
7. Other exclusion criteria per protocol.

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Michelle Darling; 858-500-7833; clinicaltrials@inhibrx.com

Contact: Kevin Bayer; clinicaltrials@inhibrx.com

• Listed Location Countries: France, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT04950075
• Other Study ID Numbers: Ph2 INBRX-109 SA CS
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Inhibrx, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Inhibrx, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Vasily Andrianov, MD; Inhibrx, Inc.

• PRS Account: Inhibrx, Inc.
• Verification Date: May 2023