> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/a-study-of-pasritamig-jnj-78278343-in-combination-with-other-e6590381-7e15-4bbc-982a-d0945f86d1f5
> Record changed: 2026-10-13

# A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer

NCT05818683

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

Phase

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

Recruitment status

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

Participants

300

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

Lead sponsor

Janssen Research & Development, LLC

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

Start date

2023-04-26

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

Number of sites

15

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

## Title and summary

**Summary**

The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of pasritamig with the combination regimens in Part 2 (dose expansion).

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Short title**

A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Official title**

A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

## Status and phase

**Control arm**

Open label

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Recruitment status**

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Phase**

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

## Dates

**Completion date**

2028-05-23

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**First posted**

2023-04-19

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Registry last updated**

2026-08-28

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Primary completion date**

2027-08-31

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Start date**

2023-04-26

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

## Size and sites

**Participants**

300

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Planned participants**

300

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Protocol amendments**

10

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Number of sites**

15

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Lead sponsor**

Janssen Research & Development, LLC

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

## Identifiers

**Registry ID**

NCT05818683

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**ClinicalTrials.gov ID**

NCT05818683

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

## Study design

**Allocation**

Not applicable

**Model**

Sequential

**Purpose**

Treatment

**Masking**

No masking

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

## Outcomes

### Primary outcomes

1. Part 1: Number of Participants With Dose Limiting Toxicity (DLT)  
Timeframe: Up to 21 days after first dose of combination agent  
DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
2. Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity  
Timeframe: Up to 2 years 11 months  
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.

### Secondary outcomes

1. Overall Response Rate (ORR)  
Timeframe: Up to 2 years 11 months  
ORR is defined as the percentage of participants who have a partial response (PR) or better without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3) criteria.
2. Prostate Specific Antigen (PSA) Response Rate  
Timeframe: Up to 2 years 11 months  
PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline.
3. Radiographic Progression-free Survival (rPFS)  
Timeframe: Up to 2 years 11 months  
rPFS is defined time from the date of first dose of pasritamig until the date of objective disease progression or death, whichever comes first.
4. Time to Response (TTR)  
Timeframe: Up to 2 years 11 months  
TTR is defined for the responders as the time from the date of first dose of to the date of first documented response that is subsequently confirmed.
5. Duration of Response (DOR)  
Timeframe: Up to 2 years 11 months  
DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first.
6. Part 2H Metastatic hormone-sensitive prostate cancer (mHSPC) Participants : Composite Progression-Free Survival (PFS)  
Timeframe: Up to 2 years 11 months  
Composite PFS is defined as time from start of treatment to the date of first occurrence of investigator determined disease progression (Response Evaluation Criteria in Solid Tumors \\\[RECIST\\\] or bone progression), pain, PSA progression, death or last disease assessment.

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

## Eligibility

**Sex**

Male

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Healthy volunteers**

No

### Inclusion criteria

- Part 1 A-G, 1I, 1J, and 1K (all combination treatments) and Parts 2B-C (cabazitaxel, docetaxel): Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by prostate cancer working group 3 (PCWG3); Parts 2D-G, 2I, 2J, and 2K (apalutamide, enzalutamide, darolutamide, abiraterone acetate + prednisone \[AAP\], lutetium Lu-177 vipivotide tetraxetan, JNJ-101556143): mCRPC: Histologically confirmed adenocarcinoma of the prostate as defined by PCWG3, with a minimum PSA of 2 nanogram \[ng\]/milliliter (mL); Part 2H (apalutamide): metastatic hormone-sensitive prostate cancer(mHSPC) with PSA greater than (>) 0.2 ng/mL on 6 to 24 months of treatment with a next generation ARPI (apalutamide, enzalutamide, darolutamide, or abiraterone)
- Measurable or evaluable disease, except for Part 2H
- (a) Part 1A (cetrelimab) - Prior treatment for mCRPC with at least 1 prior androgen receptor pathway inhibitors (ARPI) (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (example, docetaxel). (b) Part 1C and 2C (docetaxel), Part 1D (apalutamide), Part 1E and 2E (enzalutamide), Part 1F and 2F (darolutamide), and Part 1G, 2G (AAP), and Part 1K & 2K (JNJ-101556143)- Prior treatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide, darolutamide, or abiraterone acetate). (C) Part 1B and 2B (cabazitaxel) - Prior treatment with at least 1 prior ARPI (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel. (d) Part 2D (apalutamide) - Prior treatment with at least 1 prior ARPI (e) Part 2H (apalutamide)- Participant may have received up to 6 cycles of docetaxel. The last dose of docetaxel must be administered at least 2 months prior to enrollment (f) Parts 1I, 1J, 2I & 2J (lutetium Lu-177 vipivotide tetraxetan)- Prior treatment with at least 1 ARPI (abiraterone acetate, enzalutamide, darolutamide, or apalutamide). Participant must not have received prior cytotoxic chemotherapy or prior radioligand therapy (RLT) for mCRPC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ functions

### Exclusion criteria

- Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications
- Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (<=) 1 or baseline levels (except for alopecia, vitiligo, Grade <=2 peripheral neuropathy)
- Solid organ or bone marrow transplantation
- Known allergies, or intolerance to any of the components (example, excipients) of pasritamig, cetrelimab (Part 1A), cabazitaxel, Part 1B and 2B , docetaxel Part 1C and 2C , apalutamide (Part 1D and 2D and Part 2H), enzalutamide (Part 1E and 2E), darolutamide (Part 1F and 2F), or AAP (Part 1G and 2G), lutetium Lu-177 vipivotide tetraxetan (Parts 1I, 1J, 2I, and 2J), or JNJ-101556143 (Parts 1K & 2K)
- Significant infections or serious lung, heart or other medical conditions

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

## Sites

- Florida Cancer SpecialistsSarasota, United StatesRecruiting
- Start MidwestGrand Rapids, United StatesRecruiting
- Washington University School Of MedicineSt Louis, United StatesRecruiting
- Perlmutter Cancer Center at NYU Langone BrooklynBrooklyn, United StatesRecruiting
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long IslandMineola, United StatesRecruiting
- NYU Langone HealthNew York, United StatesRecruiting
- Sidney Kimmel Cancer Center - Jefferson HealthPhiladelphia, United StatesRecruiting
- Icon Cancer Centre Kurralta ParkKurralta Park, AustraliaRecruiting
- Macquarie UniversityMacquarie University, AustraliaRecruiting
- Peter MacCallum Cancer CentreMelbourne, AustraliaRecruiting
- Princess Alexandra HospitalWoolloongabba, AustraliaRecruiting
- Hosp Univ Vall D HebronBarcelona, SpainRecruiting
- Hosp Univ Fund Jimenez DiazMadrid, SpainRecruiting
- Hosp. Univ. 12 de OctubreMadrid, SpainRecruiting
- Hosp Univ Hm SanchinarroMadrid, SpainRecruiting

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

## References

### Other registry identifiers (2)

- 2022-503132-14-00
- 78278343PCR1003

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)

## Related records

### Drugs (10)

- [Abiraterone acetate](https://trialight.com/data/asset/abiraterone-acetate-2c6662c6-31e9-49ed-a022-f76f326fbd3e.md)
- [Apalutamide](https://trialight.com/data/asset/apalutamide-146fbb79-89a1-420c-bc35-0403bd284412.md)
- [Cabazitaxel](https://trialight.com/data/asset/cabazitaxel-9437ae6b-3713-457c-b52b-a71e10a81dde.md)
- [Cetrelimab](https://trialight.com/data/asset/cetrelimab-3efc0fa4-bffb-4b48-bdc8-d69f58f2bb03.md)
- [Darolutamide](https://trialight.com/data/asset/darolutamide-58582cea-cd7f-464d-b5cc-049941dce9c1.md)
- [Docetaxel](https://trialight.com/data/asset/docetaxel-3c835086-a86f-4a89-abb6-45847fbab5d6.md)
- [Enzalutamide](https://trialight.com/data/asset/enzalutamide-d1214ac0-68e5-4752-9999-977e028ec483.md)
- [Lutetium LU-177 vipivotide tetraxetan](https://trialight.com/data/asset/lutetium-lu-177-vipivotide-tetraxetan-75458631-119d-4255-b128-cf7f1a7becd4.md)
- [Pasritamig](https://trialight.com/data/asset/pasritamig-100392f9-383e-475d-b603-2b08c6f1b43a.md)
- [Prednisone](https://trialight.com/data/asset/prednisone-a5a99f90-5fbe-45c2-a625-34ba78735da6.md)

### Lead sponsors (1)

- [Janssen Research & Development, LLC](https://trialight.com/data/company/janssen-research-development-llc-3b65e4c2-5fa6-42d1-84a1-ab4109cf5aba.md)

### Conditions (1)

- [Peritoneum cancer](https://trialight.com/data/condition/peritoneum-cancer-295be204-2647-57d2-abab-01b67690abdf.md) Primary condition

### Targets (20)

- [AR](https://trialight.com/data/target/ar-a6af2dca-1d81-5967-9bce-dc5b29aacbbc.md)
- [CYP17A1](https://trialight.com/data/target/cyp17a1-593c155a-0d40-55ab-829f-9468945d0fdf.md)
- [FOLH1](https://trialight.com/data/target/folh1-d75894e5-568c-56e9-a094-d16901b86daf.md)
- [NR3C1](https://trialight.com/data/target/nr3c1-98974b8d-fb89-5483-955e-d4a994c71532.md)
- [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md)
- [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md)
- [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md)
- [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md)
- [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md)
- [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md)
- [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md)
- [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md)
- [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md)
- [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md)
- [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md)
- [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md)
- [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md)
- [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md)
- [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md)
- [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md)

---

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