A Study of FOR46 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

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).