NCT06788509

A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring

An Open Label, Rollover Platform Study for Continued Study Treatment and Ongoing Safety Monitoring

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect long-term safety data in participants with cancers including acute myeloid leukemia, non-Hodgkin lymphoma, myelodysplastic syndrome, chronic lymphocytic leukemia (type of cancer of the blood and bone marrow in which the bone marrow makes a large number of abnormal blood cells) and advanced solid tumors and metastatic castration-resistant prostate cancer (mCRPC).

Conditions

• Leukemia, Myeloid, Acute
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma, Non-Hodgkin
• Myelodysplastic Syndromes
• Neoplasms
• Solid Tumor, Adult
• Prostatic Neoplasms, Castration-Resistant

Interventions

Type	Name	Description
DRUG	JNJ-75348780	Participants from the parent study (75348780LYM1001 \[NCT04540796\]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-75348780.
DRUG	JNJ-67856633	Participants from the parent studies (64264681LYM1002 \[NCT04657224\], 67856633LYM1002 \[NCT04876092\] and 67856633LYM1001 \[NCT03900598\]) who are deriving benefit from study treatment will continue to receive JNJ-67856633 orally.
DRUG	JNJ-54179060	Participants from the parent study (67856633LYM1002 \[NCT04876092\]) who are deriving benefit from study treatment will continue to receive JNJ-54179060 orally.
DRUG	JNJ-64264681	Participants from the parent studies (64264681LYM1001 \[NCT04210219\], 64264681LYM1002 \[NCT04657224\]) who are deriving benefit from study treatment will continue to receive JNJ-64264681 orally.
DRUG	JNJ-74856665	Participants from the parent study (74856665AML1001 \[NCT04609826\]) who are deriving benefit from study treatment will continue to receive JNJ-74856665 orally.
DRUG	JNJ-70218902	Participants from the parent study (70218902EDI1001 \[NCT04397276\]) who are deriving benefit from study treatment will continue to receive JNJ-70218902 orally.
DRUG	JNJ-64619178	Participants from the parent study (64619178EDI1001 \[NCT03573310\]) who are deriving benefit from study treatment will continue to receive JNJ-64619178 orally.
DRUG	JNJ-80948543	Participants from the parent studies (80948543LYM1001 \[NCT05424822\]; and 80948543LYM1002 \[NCT06660563\]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-80948543.
DRUG	JNJ-87801493	Participants from the parent study (87801493LYM1001 \[NCT06139406\]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-87801493 in combination with subcutaneous JNJ-80948543.

Timeline

• Start date: 2024-12-30
• Primary completion: 2028-01-19
• Completion: 2028-10-30
• First posted: 2025-01-23
• Last updated: 2026-04-13

Locations

28 sites across 13 countries: Belgium, France, Georgia, Greece, Israel, Japan, Moldova, Poland, South Korea, Spain, Taiwan, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study