A Phase 2 study of INBRX-109 in adults with a type of unresectable or metastasized cancer of the bones and joints (Conventional Chondrosarcoma)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Inhibrx Biosciences Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

19 Apr 2022 → ongoing

Decision date (initial)

2024-10-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Inhibrx Biosciences Inc.

External identifiers

EU CT number

2024-517528-20-00

EudraCT number

2021-002635-35

WHO UTN

U1111-1298-2770

ClinicalTrials.gov

NCT04950075

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Diagnosis, Pharmacokinetic, Therapy

To evaluate the anticancer efficacy of INBRX-109 in the Intention To Treat (ITT) population as measured by Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECISTv1.1), assessed by central real-time indepedent radiology review (IRR), comparing INBRX-109 and placebo.

Secondary objectives 9

1. To evaluate the anticancer efficacy of INBRX-109 as measured by OS comparing INBRX-109 and placebo.
2. To evaluate the anticancer efficacy of INBRX-109 as measured by overall response rate (ORR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo.
3. To evaluate the anticancer efficacy of INBRX-109 as measured by PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo.
4. To evaluate quality of life (QoL), as measured by European Organization for Research and Treatment of Cancer quality of life questionnaire C30 (EORTC QLQ-C30) Pain and Physical Functioning scales, comparing INBRX-109 and placebo.
5. To evaluate the anticancer efficacy of INBRX-109 as measured by disease control rate (DCR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo.
6. To evaluate duration of response (DOR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo.
7. To evaluate the safety and tolerability of INBRX-109.
8. To characterize the Pharmacokinetics (PK) of INBRX-109.
9. To evaluate the frequency of ADAs, and neutralizing ADA (NAbs), against INBRX-109 and to explore the potential relationship with safety, PK, and efficacy of INBRX-109.

Conditions and MedDRA coding

Unresectable or metastatic conventional chondrosarcoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Males or females aged ≥ 18 to ≤ 85 years
2. Conventional (or primary) chondrosarcoma, unresectable (i.e., not amenable to tumor resection with curative intent) or metastatic. Availability of archival tissue or fresh cancer biopsy are mandatory.
3. 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.
4. Evidence of confirmed radiographic disease progression per RECISTv1.1 criteria within 6 months prior to start of study treatment.
5. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
6. ECOG PS of 0 or 1 (Exception: Inclusion of non-frail, physically active patients with compromised mobility due to prior cancer surgery (eg, limb amputation, hemipelvectomy) should be discussed with the Medical Monitor or Study Director)
7. Estimated life expectancy, in the documented judgment of the Investigator, of at least 12 weeks.

Exclusion criteria 6

1. Any prior exposure to DR5 agonists.
2. Allergy or sensitivity to INBRX-109 or known allergies to Chinese hamster ovary (CHO) cell-produced antibodies, which in the opinion of the Investigator suggest an increased potential for an adverse hypersensitivity to INBRX-109.
3. Non-conventional CSs, eg, clear-cell, mesenchymal, extra-skeletal myxoid, myxoid, and dedifferentiated CS.
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. Any evidence or history of multiple sclerosis (MS) or other demyelinating disorders.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression Free Survival (PFS) per RECISTv1.1 assessed by central IRR in the ITT population

Secondary endpoints 9

1. Overall Survival (OS) in the ITT Population
2. ORR per RECISTv1.1 by central real-time IRR.
3. PFS per RECISTv1.1 by Investigator assessment.
4. QoL per EORTC QLQ-C30 (Pain and Physical Function).
5. DCR per RECISTv1.1 by central real-time IRR.
6. DOR per RECISTv1.1 by central real-time IRR.
7. Treatment emergent adverse events (TEAEs) including Serious adverse event (SAEs).
8. PK characterization: AUC0-inf, AUC0-last, AUC0-21d, Cmax, Ctrough, Tmax will be estimated using a standard non-compartmental method as the data allow. Other PK parameters (λz, t½, Vd, CL, and accumulation ratios RCmax, RCtrough) will be calculated if data permit.
9. Frequency of ADAs and Nabs.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Inhibrx Biosciences Inc.

Sponsor organisation

Inhibrx Biosciences Inc.

Address

11025 North Torrey Pines Road Suite 140

City

La Jolla

Postcode

92037-1030

Country

United States

Scientific contact point

Organisation

Inhibrx Biosciences Inc.

Contact name

Study Director - Inhibrx

Public contact point

Organisation

Inhibrx Biosciences Inc.

Contact name

Study Director - Inhibrx

Third parties 8

Locations

6 EU/EEA countries · 30 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 72 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications