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NCT07477587 · ClinicalTrials.gov registry record · Phase 1
A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma
A Phase 1 study, sponsored by Shanghai Henlius Biotech.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 258
- Enrollment target
NCT07477587: Recruiting Phase 1 study, sponsored by Shanghai Henlius Biotech.
NCT07477587 is a Phase 1 study that is actively recruiting participants, run by Shanghai Henlius Biotech. The registered enrollment target is 258 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (330% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07477587, a Phase 1 study, is actively recruiting participants, sponsored by Shanghai Henlius Biotech.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 258 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the pharmacokinetic (PK) similarity, safety, tolerability, immunogenicity, and efficacy of HLX15-SC versus US-DARZALEX FASPRO® following single and multiple subcutaneous (SC) injections in newly diagnosed MM patients ineligible for transplant. Participants who meet all inclusion criteria and none of the exclusion criteria will receive either the HLX15-SC-Rd regimen or the D-Rd regimen for 4 cycles (one cycle = 4 weeks). After 4 cycles of treatment, based on clinical benefit and participant preference, participants may continue to receive the locally marketed daratumumab subcutaneous formulation (Dara-SC) in combination with Rd according to clinical practice, up to 32 weeks or until loss of clinical benefit, death, unacceptable toxicity, withdrawal of informed consent, or any other protocol-specified reason, whichever occurs first. After 32 weeks of dosing, participants will continue to receive appropriate standard of care according to local guidelines (including marketed Dara-SC).
Primary Outcome
Area under the serum concentration-time curve from time 0 to day 7 (AUC0-7d) after the 1st dose.
Interventions
- DRUG HLX15-SC-Rd
- DRUG US-DARZALEX FASPRO®-Rd
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2026-05-27 |
| Est. Completion | 2028-02-22 |
| Phase | Phase 1 |
What NCT07477587 shows while recruiting
NCT07477587 is an interventional study that assigns participants to a tested intervention. The registered 258 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (330% higher).
The record links to 0 conditions, and to 2 interventions - of which HLX15-SC-Rd is the first listed.
NCT07477587 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07477587 about?
NCT07477587 is a clinical study titled "A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma". The purpose of this study is to compare the pharmacokinetic (PK) similarity, safety, tolerability, immunogenicity, and efficacy of HLX15-SC versus US-DARZALEX FASPRO® following single and multiple subcutaneous (SC) injections in newly diagnosed MM patients ineligible for transplant. Participants wh...
What is the current status of trial NCT07477587?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 258 participants. The study started on 2026-05-27. Estimated completion is 2028-02-22.
What interventions are being tested in trial NCT07477587?
The interventions under investigation include: HLX15-SC-Rd (DRUG), US-DARZALEX FASPRO®-Rd (DRUG).
Who is sponsoring clinical trial NCT07477587?
This trial is sponsored by Shanghai Henlius Biotech, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07477587's enrollment target sits among peer trials
258 167th of 2000 higher than 1,833 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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