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Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma

Cancer Type
Multiple Myeloma
Trial Phase
Phase I
Phase II
18 Years and older, Male and Female
Study Type
Protocol IDs
HDP-101-01 (primary)
Study Sponsor
Heidelberg Pharma AG


This study will assess the safety, tolerability, pharmacokinetics (PK) and the
therapeutic potential of HDP-101 in patients with plasma cell disorders including
multiple myeloma.


The study will consists of two parts: a Part 1 dose escalation phase and a Part 2a
expansion phase for safety, tolerability, PK, PD, and clinical activity testing. The
study will enroll subjects with relapsed/refractory MM or other plasma cell disorders
expressing BCMA. An adaptive 2-parameter Bayesian logistic regression model (BLRM) for
dose-escalation with overdose control will be used in the dose-escalation phase for
determination of the MTD or the RP2D. Dose-expansion phase of the study aims to collect
preliminary evidence of antitumor activity and to confirm the safety of the HDP-101 as a


  1. Male or female aged =18 years.
  2. Life expectancy >12 weeks.
  3. Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2.
  4. A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).
  5. Must have undergone SCT or is considered transplant ineligible.
  6. Must have undergone prior treatments with antimyeloma therapy which must have included an immunomodulatory drug, proteasome inhibitor, and anti-CD38 treatment, alone or in combination. 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.
  7. Measurable disease as per IMWG criteria.
  8. Adequate organ system function as defined in protocol.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.