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NeoplasmsPhase 1NCT04991740

A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors

A Phase 1 study testing JNJ-78306358 in people with Neoplasms, run by Janssen Research & Development, LLC at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the recommended phase 2 dose (RP2D) regimen(s) of JNJ-78306358 in Part 1 (Dose Escalation) and to determine the safety of JNJ-78306358 at the RP2D regimen(s) in Part 2 (Dose Expansion). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
JNJ-78306358
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
5 sitesin 2 countries
Study dates
24 Oct 2021to 9 Feb 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed, metastatic or unresectable solid tumor of one of the following types:
  • Renal Cell Carcinoma (RCC): clear cell or papillary carcinoma, b. ovarian cancer: high grade serous epithelial ovarian; primary peritoneal or fallopian tube cancer; 1. low grade or non-serous histologies are not allowed; c. colorectal cancer (CRC); d. other tumor types (including lung adenocarcinoma, endometrial cancer, and pancreas cancer) may be enrolled with sponsor approval
  • Measurable or evaluable disease: a. Part 1: either measurable or evaluable disease; b. Part 2: at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Participants with ovarian cancer without a measurable lesion must have disease evaluable per RECIST version1.1 (example ascites) or have Cancer antigen 125 (CA 125) greater than (>) 2*upper limit of normal (ULN) within 2 weeks prior to first dose of study drug
  • Progressed during or after the following prior therapies for metastatic disease, unless participant was ineligible to receive them: a) RCC: clear cell histology: an antiangiogenic agent and an immune checkpoint inhibitor, administered as 1 or more lines of therapy. For papillary renal carcinoma 1 line of systemic therapy; b. CRC: at least 2 lines of therapy including a fluoropyrimidine, oxaliplatin, and irinotecan given with or without antiangiogenic therapies or epidermal growth factor receptor (EGFR) antibodies. In addition, prior treatment with anti-programmed cell death protein 1 (PD1) antibody is required for high microsatellite instability (MSI-H) CRC; c. ovarian cancer: at least 2 lines of therapy, including at least 1 line with platinum. Maintenance therapy after completion of platinum-containing regimen, example with bevacizumab or a poly- Adenosine di-phosphate (ADP) ribose polymerase inhibitor will not count as a separate line of therapy; d. other tumor types: at least 2 lines of systemic therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
  • Selected participants in pharmacokinetics/pharmacodynamic (PK/PD) cohorts and in Part 2 must agree to undergo the mandatory tumor biopsies

Who cannot join

  • Active central nervous system involvement
  • Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be Grade 2)
  • Clinically significant pulmonary compromise
  • Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug
  • Solid organ or bone marrow transplantation

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Spain3 sites

  • Hosp. Univ. Vall D Hebron

    Barcelona, 8035

  • Hosp. Univ. Fund. Jimenez Diaz

    Madrid, 28040

  • Hosp. Univ. Hm Sanchinarro

    Madrid, 28050

Other trials in Spain

Israel2 sites

  • Rambam Medical Center

    Haifa, 31096

  • Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

About this study

Official title: A Phase 1 Study of JNJ-78306358, a T Cell Redirecting Bispecific Antibody Targeting HLA-G for Advanced Stage Solid Tumors

The purpose of this study is to determine the recommended phase 2 dose (RP2D) regimen(s) of JNJ-78306358 in Part 1 (Dose Escalation) and to determine the safety of JNJ-78306358 at the RP2D regimen(s) in Part 2 (Dose Expansion).

Read the detailed description

JNJ-78306358 is a bispecific antibody binding to CD3 on T cells and human leukocyte antigen G (HLA-G) on cancer cells. The study consists of a screening phase, a treatment phase, and a post-treatment follow-up phase. Study evaluations include safety, pharmacokinetics, biomarkers, immunogenicity, and efficacy (disease evaluations). The total study duration will be up to 2 years 4 months.

Conditions
Neoplasms
Being tested
JNJ-78306358
Keywords
Kidney cancer, Ovarian cancer, Colorectal cancer
Medical subject headings
Neoplasms, Kidney Neoplasms, Ovarian Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-78306358Drug

    JNJ-78306358 will be administered.

Study groups in NCT04991740
Study groupRoleWhat they receive
Part 1: Dose EscalationExperimentalParticipants with renal cell carcinoma (RCC), ovarian cancer, colorectal cancer (CRC), and other tumor types with sponsor approval will receive JNJ-78306358. The dose will be escalated sequentially based on the decisions of the study evaluation team until the recommended phase 2 dose (RP2D) regimen(s) have been identified.
Receives: Drug: JNJ-78306358
Part 2: Dose ExpansionExperimentalParticipants with RCC, ovarian cancer, CRC and other types of tumors will receive JNJ-78306358 at the RP2D regimen(s) determined in Part 1.
Receives: Drug: JNJ-78306358

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Incidence of Adverse Events (AEs)

    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.

    Measured: Up to 2 years and 4 months

  2. Number of Participants with AEs by Severity

    Number of participants with AEs by severity will be reported. 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 (ICANS) events, which will be graded according to the 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.

    Measured: Up to 2 years and 4 months

  3. Part 1: Number of Participants with Dose-limiting Toxicity (DLT)

    Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

    Measured: Up to 21 days

Secondary outcomes (7)

  1. Maximum Serum Concentration (Cmax) of JNJ-78306358

    Cmax is defined as maximum serum concentration of JNJ-78306358.

    Measured: Up to 2 years and 4 months

  2. Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-78306358

    Tmax is defined as time to reach maximum observed serum concentration of JNJ-78306358.

    Measured: Up to 2 years and 4 months

  3. Area Under the Serum Concentration-time Curve From Time t1 to t2 (AUC[t1-t2]) of JNJ-78306358

    AUC(t1-t2) is defined as the area under the serum concentration-time curve from time t1 to t2.

    Measured: Up to 2 years and 4 months

  4. Accumulation Ratio (RA) of JNJ-78306358

    RA is calculated as area under the plasma concentration-time curve from time zero to 24 hours (AUC [0-24]) value at steady state divided by AUC (0-24) value after first dose.

    Measured: Up to 2 years and 4 months

  5. Number of Participants with Anti-JNJ-78306358 Antibodies

    Number of participants with anti-JNJ-78306358 antibodies will be reported.

    Measured: Up to 2 years and 4 months

  6. Overall Response Rate (ORR)

    ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR), according to response evaluation criteria in solid tumors (RECIST) version 1.1 and gynecological cancer inter group (GCIG) Cancer antigen 125 (CA 125) response criteria (for ovarian cancer participants only).

    Measured: Up to 2 years and 4 months

  7. Duration of Response (DOR)

    Duration of response (DOR) will be calculated among responders (PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the RECIST version 1.1 response criteria and GCIG CA 125 response criteria (for ovarian cancer participants only) or death due to any cause, whichever occurs first.

    Measured: Up to 2 years and 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2021
  2. Study start24 Oct 2021
  3. Primary completion9 Feb 2023
  4. Study completion9 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04991740
Sponsor's protocol ID
CR109028
Other IDs
2021-001646-35, 78306358STM1001
Status last verified
Mar 2023
First submitted
2 Aug 2021
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Publications

  • Geva R, Vieito M, Ramon J, Perets R, Pedregal M, Corral E, Doger B, Calvo E, Bardina J, Garralda E, Brown RJ, Greger JG, Wu S, Steinbach D, Yao TS, Cao Y, Lauring J, Chaudhary R, Patel J, Patel B, Moreno V. Safety and clinical activity of JNJ-78306358, a human leukocyte antigen-G (HLA-G) x CD3 bispecific antibody, for the treatment of advanced stage solid tumors. Cancer Immunol Immunother. 2024 Aug 6;73(10):205. doi: 10.1007/s00262-024-03790-7.

    PubMed 39105878

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-78306358 in people with Neoplasms, run by Janssen Research & Development, LLC at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Incidence of Adverse Events (AEs) (time frame: Up to 2 years and 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04991740, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.

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