Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
Study Details
Study Description
Brief Summary
This study is a first-in-human (FIH), Phase 1/1b, open-label, multicenter dose escalation and dose expansion study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of JANX008 in adult subjects with advanced or metastatic carcinoma expressing EGFR.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dose Escalation Subjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose. |
Drug: JANX008
JANX008 is dosed via IV weekly in a 21-day cycle
|
| Experimental: Backfill Expansion Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable. |
Drug: JANX008
JANX008 is dosed via IV weekly in a 21-day cycle
|
| Experimental: Expansion Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D). |
Drug: JANX008
JANX008 is dosed via IV weekly in a 21-day cycle
|
Outcome Measures
Primary Outcome Measures
- Incidence of Dose Limiting Toxicities (DLT) [21 days]
- Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) [Up to 4 years]
- Incidence of Clinically Significant Laboratory Abnormalities [Up to 4 years]
Secondary Outcome Measures
- Area under the concentration time curve from time 0 to last timepoint prior to next dose JANX008 (AUC last) [Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 4 years)]
- Maximum observed concentration of JANX008 (Cmax) [Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 4 years)]
- Number of participants who develop anti-drug antibodies against JANX008 [Up to 4 years]
- Overall Response Rate [Up to 4 years]
Proportion of participants who achieve a complete response or partial response per RECIST v1.1
- Duration of Response [Up to 4 years]
Time from documentation of CR or PR to disease progression per RECIST v1.1
- Progression Free Survival [Up to 4 years]
Time from treatment initiation to disease progression per RECIST v1.1
- Correlation of EGFR expression level with anti-tumor activity and safety [Up to 4 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects ≥18 years of age at the time of signing informed consent
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Histologically or cytologically documented locally advanced or metastatic NSCLC, SCCHN, CRC, or RCC
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Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for the tumor type
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Adequate organ function
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At least 1 measurable lesion per RECIST 1.1
Exclusion Criteria:
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Treatment with anti-cancer therapy within 28 days or ≤5 elimination half-lives, whichever is earlier, before enrollment
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Prior treatment with EGFR-targeted bispecific T cell engager or CAR-T cell therapy
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Prior treatment with CD3 engaging bispecific antibodies
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Clinically significant cardiovascular diseases
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Active clinically significant infection (bacterial, viral, fungal, mycobacteria, or other)
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On supplemental oxygen
-
Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City of Hope Medical Center | Duarte | California | United States | 91010 |
Sponsors and Collaborators
- Janux Therapeutics
Investigators
- Study Director: Janux Therapeutics, MD, Janux Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EGFR-008-001