Clinical trial · Interventional
A Study of FOR46 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
A Phase I Study of FOR46 Administered Every 21 Days in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
NCT03650491CI-TRIAL-00059910completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will test the safety and efficacy of FOR46 given every 21 days to patients with relapsed or refractory multiple myeloma. The name of the study drug involved in this study is: FOR46 for Injection
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Multiple Myeloma in Relapse | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Multiple Myeloma With Failed Remission | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOR46 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: FOR46 (Dose Escalation)
- description
- Eligible patients will receive FOR46 administered as an IV infusion every 21 days. Patients will be enrolled into escalating dose levels during the Dose Escalation period of the study.
- interventionNames
- Drug: FOR46
- type
- EXPERIMENTAL
- label
- Experimental: FOR46 (Dose Expansion)
- description
- Eligible patients will receive FOR46 administered as an IV infusion every 21 days. Patients will receive the maximum tolerated dose during the Dose Expansion period of the study.
- interventionNames
- Drug: FOR46
Primary outcomes (3)
- measure
- Incidence of adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female ≥ 18 years of age * Measurable MM that is relapsed or refractory to established therapies with known clinical benefit in RRMM or intolerant of those established MM therapies. Prior lines of therapy must include a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD) and a CD38-directed therapy in any order of combination. * ECOG performance status of 0 or 1 * Adequate hematologic, renal and hepatic function * Females of child-bearing potential must have a negative serum pregnancy test and use a medically acceptable form of contraception * Male patients with with female partners of childbearing potential must agree to use 2 effective methods of contraception * Patients must provide signed informed consent Exclusion Criteria: * Persistent clinically significant toxicities from previous anticancer therapy * NCI CTCAE Grade ≥ 2 peripheral neuropathy from any etiology or has a genetic disorder that is associated with peripheral neuropathy even without current neuropathic manifestations * Has received treatment with a stem cell transplant within 12 weeks before administration of patient's first dose of FOR46 * Has had radiation or systemic anticancer therapy within 14 days before first dose of FOR46 * Has received treatment with an investigational drug within 28 days before first dose of FOR46 * Has had a major surgical procedure within 28 days before administration of the patient's first FOR46 dose * Is breastfeeding * Clinically significant cardiovascular disease * Uncontrolled, clinically significant pulmonary disease * Uncontrolled intercurrent illness * Has known positive status for HIV or either active/chronic hepatitis B/C * Requires anticoagulation with warfarin or direct thrombin inhibitor; a washout of 7 days before the administration of a patient's first FOR46 dose is required for patients removed from these treatments * Requires medications that are strong inhibitors or strong inducers of CYP3A4 * Has a history of episodic atrial fibrillation or flutter; patients with chronic atrial fibrillation are not excluded. * Prior treatment with an ADC containing Monomethyl auristatin E (MMAE) or Monomethyl auristatin F (MMAF).
References
Publications (0)
Data not yet available
No reference posted for this study.