A Study of Lorigerlimab with Docetaxel or Docetaxel Alone in Participants with Metastatic Castration-Resistant Prostate Cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Macrogenics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

15 Jul 2024 → 16 Mar 2026

Decision date (initial)

2023-09-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

MacroGenics, Inc.

External identifiers

EU CT number

2022-502982-49-00

WHO UTN

U1111-1291-5117

ClinicalTrials.gov

NCT05848011

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Pharmacodynamic, Efficacy, Others, Safety

To evaluate the efficacy of lorigerlimab+docetaxel versus docetaxel as measured by rPFS.

Secondary objectives 7

1. To evaluate the efficacy of lorigerlimab+docetaxel versus docetaxel as measured by objective response assessments.
2. To evaluate the efficacy of lorigerlimab+docetaxel versus docetaxel as measured by PSA levels.
3. To characterize the safety/tolerability profile of lorigerlimab+docetaxel versus docetaxel.
4. To evaluate the efficacy of lorigerlimab+docetaxel versus docetaxel as measured by OS.
5. To characterize the PK of lorigerlimab.
6. To characterize immunogenicity of lorigerlimab.
7. To evaluate QOL outcomes associated with lorigerlimab+docetaxel versus docetaxel as measured by disease-related symptoms and participant-reported outcomes.

Conditions and MedDRA coding

Metastatic Castration-Resistant Prostate Cancer

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Metastatic castration-resistant adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features.
2. Participants must have ≥ 1 metastatic (measurable or non-measurable per PCWG3) lesion.
3. Participant has prostate cancer progression at study entry based on PCWG3 criteria.
4. Participant shows evidence of disease progression after receiving at least 1 prior androgen receptor axis-targeted therapy (ARAT) regimen (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide).
5. Patients with known history of documented breast cancer gene (BRCA) mutation (germline or somatic) must have received an approved poly ADP ribose polymerase (PARP) inhibitor regimen.
6. Participants must have adequate performance status, life expectancy and laboratory values.

Exclusion criteria 5

1. Any condition preventing participant’s ability to receive, tolerate, or comply with the planned treatment or study procedures.
2. Received prior chemotherapy for mCRPC or prior treatment with checkpoint inhibitors for prostate cancer.
3. Current active or chronic infections.
4. Any clinically significant heart, lung, or gastrointestinal disorders.
5. Allergy to any of the study treatments or components of the study treatments.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Median radiographic progression free survival (rPFS) determined by investigator review.

Secondary endpoints 21

1. Objective response rate (ORR) per PCWG3 criteria
2. Duration of response (DoR)
3. Time to response (TTR)
4. PSA50 response rate
5. PSA90 response rate
6. Time to PSA progression
7. Duration of PSA response
8. Overall survival (OS)
9. Time to First Symptomatic Skeletal Event (SSE)
10. Time to pain progression using the BPI-sf questionnaire
11. Pain severity using the Brief Pain Index - short form (BPI-sf) questionnaire
12. Pain interference using the BPI-sf questionnaire
13. Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire
14. Comparison of types of adverse events (AEs) between treatment groups
15. Lorigerlimab maximum concentration or concentration at the end of infusion (Cmax)
16. Lorigerlimab area under the concentration time curve (AUC)
17. Trough drug concentration (Ctrough or Cmin)
18. Clearance (CL)
19. Volume of distribution (Vz)
20. Terminal half-life
21. Number of participants who develop anti-drug antibodies

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Macrogenics Inc.

Sponsor organisation

Macrogenics Inc.

Address

9704 Medical Center Drive

City

Rockville

Postcode

20850-3343

Country

United States

Scientific contact point

Organisation

Macrogenics Inc.

Contact name

Study Physician

Public contact point

Organisation

Macrogenics Inc.

Contact name

Global Trial Manager

Third parties 9

Locations

5 EU/EEA countries · 32 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 5 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 57 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

15 submissions — initial application plus substantial / non-substantial modifications