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 AG9 sites in 3 countries71 target enrollmentAugust 23, 2024

DrugsHDP-101

Overview

Phase: Phase 1/2
Intervention: Not specified
Conditions: Not specified
Sponsor: Heidelberg Pharma AG
Enrollment: 71
Locations: 9
Primary Endpoint: Phase 1: Number of patients who experience a dose-limiting toxicity (DLT) during the first cycle of treatment. Phase 2a: Objective response rate (ORR).
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Phase 1: Determine the maximum tolerable dose (MTD) for each treatment arm and/or select a recommended Phase 2 dose for HDP-101 as monotherapy in patients with relapsed or refractory multiple myeloma (r/r MM).

Phase 2a: Assess efficacy of HDP-101

Registry

euclinicaltrials.eu

Start Date

August 23, 2024

End Date

TBD

Last Updated

11 months ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Heidelberg Pharma AG

Responsible Party

Principal Investigator

Clinical Development

Scientific

Heidelberg Pharma AG

Eligibility Criteria

Inclusion Criteria

•Patients who have signed an informed consent and are willing to comply with the requirements and restrictions listed in the study protocol.
•Adequate organ system function as defined: •Absolute neutrophil counta: ≥1.0 × 10^9/L •Platelet count: ≥75 × 10^9/L and absent platelet transfusion for ≥7 days •Hemoglobin: >8.0 g/dL and absent RBC transfusion for ≥7 days •Activated partial thromboplastin time/partial thromboplastin time: ≤1.5 × ULN •Measured CrCl (using 24-hour urine), if a measured CrCl is not available, the calculated creatinine clearance using the Cockcroft-GaultFormula can be used: ≥60 mL/min •Albuminuria: ≤500 mg/24 hours •Total serum bilirubin: ≤1.5 × ULN (isolated bilirubin >1.5 and ≤3.0 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) •Aspartate and alanine transaminases: ≤1.5 × ULN
•A female patient is eligible to participate if she is of •Nonchildbearing potential defined as premenopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle-stimulating hormone >40 MIU/mL and estradiol <40 pg/mL [<147 pmol/L] is confirmatory). Women on hormone replacement therapy and whose menopausal status is in doubt are treated like women of childbearing potential unless they discontinue their HRT to allow confirmation of postmenopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their postmenopausal status, they can resume use of HRT during the study without use of a contraceptive method. •Women of childbearing potential must have a negative urine pregnancy test 7 days before the first administration of the study treatment and on Day 1 before first dose of study treatment and commit to either abstain continuously from heterosexual intercourse or to use 2 methods of reliable birth control simultaneously, during the study and for 4 months following the last dose of the study treatment. This includes 1 highly effective form of contraception (tubal ligation, intrauterine device, hormonal [birth control pills, injections, hormonal patches, vaginal rings, or implants] or partner's vasectomy) and 1 additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap).
•Male patients must have had a prior vasectomy or commit to use an effective contraception (complete abstinence from sexual intercourse, latex or synthetic condom and during sexual intercourse with a female a double-barrier method including a condom and occlusive cap [diaphragm or cervical/vault caps] plus spermicidal agent [foam/gel/film/cream/suppository]) from the time of first study treatment infusion until 3 months following the last study treatment infusion to allow for clearance of any altered sperm.
•Male or female aged ≥18 yrs at the time of informed consent.
•Life expectancy >12 weeks, as determined by the Investigator.
•ECOG Performance Status (PS) of 0 to 2 (tumor related performance).
•A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).
•Must have undergone SCT or is considered transplant ineligible.
•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.

Exclusion Criteria

•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).
•Symptomatic graft versus host disease post allogenic hemopoietic cell transplant within 12 months prior to the first study treatment infusion.
•Significant surgical intervention within 21 days prior to the first study treatment infusion or ongoing post-operative complications.
•Patients who have a history of being nonresponsive to platelet and/or RBC transfusions and expected lack of adequate support with blood products on demand.
•Radiotherapy within 21 days prior to the first study treatment infusion, or localized palliative radiotherapy within 7 days prior to the first study treatment infusion, therapy with radio immuno-conjugates performed less than 3 months prior to the first dose of study treatment.
•Herbal remedies interfering or stimulating the metabolic pathways (eg, mistletoe extract) or known to potentially interfere with major organ function (eg, hypericin) within 21 days prior to the first study treatment infusion.
•History of any other malignancy known to be active, with the exception of completely removed in situ cervical intraepithelial neoplasia, nonmelanoma skin cancer, ductal carcinoma in situ, early stage prostate cancer that has been adequately treated. Malignancies which are adequately treated and requiring hormonal therapies only to prevent the recurrence of the malignancy other than multiple myeloma may be permitted after discussion with and agreement of the Sponsor's Medical Monitor (eg, breast cancer treated with hormonal therapies).
•For sites in Germany: HIV infection at the time of the screening. For all other sites: Known human immunodeficiency virus infection.
•Patients with active infection requiring systemic anti-infective (eg, antibiotic or antiviral) therapy. Patients who are successfully treated with systemic anti-infective treatment and have no clinical signs of infection for at least 2 days may be enrolled as per the discretion of the Investigator.
•Patients positive for hepatitis B surface antigen or Hepatitis B core antigen.

Outcomes

Primary Outcomes

Phase 1: Number of patients who experience a dose-limiting toxicity (DLT) during the first cycle of treatment. Phase 2a: Objective response rate (ORR).