A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients with Plasma Cell Disorders Including Multiple Myeloma

Heidelberg Pharma AG0 sites130 target enrollmentMarch 24, 2021

ConditionsRelapsed or refractory Multiple Myeloma (r/r MM)MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsed or refractory Multiple Myeloma (r/r MM)
Sponsor: Heidelberg Pharma AG
Enrollment: 130
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 24, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Heidelberg Pharma AG

Eligibility Criteria

Inclusion Criteria

•Patients are eligible to be included in the study only if all following criteria apply:
•1\.Patients who have signed an informed consent and are willing to comply with the requirements and restrictions listed in the study protocol.
•2\.Male or female aged \=18 years at the time of informed consent.
•3\.Life expectancy \>12 weeks, as determined by the Investigator.
•4\.Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2 (tumor related performance).
•5\.A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).
•6\.Must have undergone SCT or is considered transplant ineligible.
•7\.Must have undergone prior treatments with antimyeloma therapy which must have included an immunomodulatory drug, proteasome inhibitor, and antiCD38 treatment, alone or in combination. Patients who are intolerant to these therapies or have contraindications are eligible if other eligibility criteria are fulfilled. Patient must have failed last line of treatment (refractory to or relapsed after last line of treatment) or had to permanently discontinue the last line of therapy due to toxicity (toxicity and reason for permanent discontinuation has to be documented in the electronic case report form \[eCRF]). In addition, the patient should either refractory or intolerant to any established standard of care therapy providing a meaningful clinical benefit for the patient assessed by the Investigator.
•8\.a)Phase 1 part only: patients with non\-secretory or oligo\-secretory myeloma (NSMM) not meeting the measurability criteria described in
•8\.b)are eligible (all other eligibility criteria must apply).

Exclusion Criteria

•Patients are excluded from the study if any of the following criteria apply:
•1\. For patient entering the Phase 2a part only: Prior treatment with any approved or experimental BCMA\-targeting modalities are not allowed including but not limited to chimeric antigen receptor T or NK cell treatment, mono or bispecific antibodies and other BCMA\-ADCs. (Note that patients in the Phase 1 part could have had any prior BCMA directed treatment providing they fulfilled all other I/E criteria).
•2\. History of allergic reactions to any component of the study treatment.
•3\. Known central nervous system involvement.
•4\. Plasma cell leukemia (total plasma cell count of at least 2 × 10^9/L) at Screening.
•5\. History of congestive heart failure classified as Class \= III based on the NYHA Classification or Grade 3/4 unstable angina pectoris within 6 months of enrollment, presence of unstable atrial fibrillation, ECG with QTc \=480 ms, cardiac arrhythmia, or uncontrolled hypertension.
•6\. Treatment with systemic anticancer therapy within 4 weeks or 5 t½s of the agent if t½ is known (whichever is shorter) before first dose of the study treatment. Anticancer therapies include cytotoxic chemotherapy, targeted inhibitors, and immunotherapies, but do not include radiotherapy or corticosteroids.
•7\. Higher dose of systemic corticosteroids, defined as oraldexamethasone \>40 mg/day (for patients aged \>75 years reduced to \>20 mg/day) or equivalent, within 3 days prior to the first study treatment infusion.
•8\. Currently participating in a study and receiving study therapy or participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks of the first dose of study treatment.
•9\. Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT.