ClinicalTrials.gg
Active, not recruitingNCT04950075ChonDRAgonUpdated Jul 14, 2026

Study of INBRX-109 in Conventional Chondrosarcoma

A Phase 2 interventional study of INBRX-109 and Placebo in Conventional Chondrosarcoma, sponsored by Inhibrx Biosciences, Inc. Active, not recruiting at 68 sites in 9 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Inhibrx Biosciences, Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
206
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.

Read the 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).

02

Conditions studied

  • Conventional Chondrosarcoma

Browse trials for

Keywords

  • DR5
  • INBRX-109
  • Apoptosis
  • Programmed cell death
03

In context

Chondrosarcoma

99 studies on the registry are indexed under Chondrosarcoma; 20 are open to participants now.

This study's enrollment of 206 is above the median of 52 across 72 interventional studies indexed under Chondrosarcoma.

Browse Chondrosarcoma studies →

Lead sponsor

Inhibrx Biosciences, Inc is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Conventional chondrosarcoma, unresectable (=inoperable) or .
  2. 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. performance status (ECOG PS) of 0 or 1.
  6. Estimated of at least 12 weeks.
  7. Availability of or fresh cancer biopsy are mandatory.

Exclusion criteria

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 . 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
206 participants (actual)

Study arms

  • Experimental
    INBRX-109

    IV every three weeks

    Drug: INBRX-109

  • Placebo comparator
    Placebo

    IV every three weeks

    Drug: Placebo

Interventions

  • DrugINBRX-109

    Tetravalent DR5 Agonist Antibody

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Progression-free survival per RECISTv1.1 by real time IRR comparing INBRX-109 and placebo

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

    Time frame: 3 years

Secondary outcomes

  1. Overall survival of patients comparing INBRX-109 and placebo

    Overall Survival in the ITT population

    Time frame: 3 years

  2. ORR per RECISTv1.1 by real-time IRR.

    Tumor response will be determined by RECISTv1.1.

    Time frame: 3 years

  3. PFS per RECISTv1.1 by Investigator assessment

    PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo.

    Time frame: 3 years

  4. Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo

    Quality of life will be determined.

    Time frame: 3 years

  5. DCR per RECISTv1.1 by real-time IRR

    measured by DCR per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo

    Time frame: 3 years

  6. DOR per RECISTv1.1 by real-time IRR

    evaluate duration of response (DOR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo

    Time frame: 3 years

  7. To evaluate the safety and tolerability 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: 3 years

  8. Characterize the pharmacokinetics of INBRX-109.

    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.

    Time frame: 3 years

  9. Immunogenicity of INBRX-109

    Frequency of anti-drug antibodies against INBRX-109 will be determined.

    Time frame: 3 years

Other outcomes

  1. Evaluate Quality of Life

    QoL per EORTC QLQ-C30, EQ-5D-5L, PGI-C, PGI-S

    Time frame: 3 years

  2. Potential predictive response biomarkers

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

    Time frame: 3 years

  3. PFS per RECISTv1.1 by Investigator assessment

    evaluate the anticancer efficacy of INBRX-109 as measured by PFS (by Investigator assessment) for crossover population after treatment with INBRX-109

    Time frame: 3 years

  4. ORR per RECISTv1.1 by Investigator assessment

    evaluate the anticancer efficacy of INBRX-109 as measured by ORR (by Investigator assessment) for crossover population after treatment with INBRX-109

    Time frame: 3 years

07

Study locations

68 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2021 to primary completion in Sep 2025, 48 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 14, 2021
First posted
Jul 6, 2021
StartActual
Sep 23, 2021
Primary completionActual
Sep 30, 2025
CompletionEst.
Dec 2026
Results delay requested
Jul 9, 2026
Last update
Jul 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04950075
Lead sponsor
Inhibrx Biosciences, Inc
Responsible party
Sponsor
First posted
Jul 6, 2021
Start date
Sep 23, 2021
Primary completion
Sep 30, 2025
Completion
Dec 2026 (estimated)
Last update
Jul 14, 2026

Study contacts

Clinical Lead
study director · Inhibrx Biosciences, Inc

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion