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Ovarian CancerPhase 1LNCB74-01NCT06774963

A Phase 1 Study of LNCB74 in Advanced Solid Tumors

A Phase 1 study testing LNCB74 in people with Ovarian Cancer and Breast Cancer, run by LigaChem Biosciences, Inc. at 17 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and / or recommended phase 2 dose of LNCB74 in participants with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ovarian Cancer, Breast Cancer, Endometrial Cancer
What is being tested?
LNCB74
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
17 sitesUnited States
Study dates
7 Jan 2025to Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • The participant provides written informed consent
  • ≥ 18 years of age on day of signing informed consent.
  • Participant with histologically or cytologically confirmed diagnosis of advanced unresectable and/or metastatic solid tumors
  • A male participant must agree to use contraception and refrain from sperm donation or expecting to father a child
  • A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential
  • Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
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  • Able to provide tumor tissue sample.
  • Willing to undergo fresh tumor biopsy at Screening and On-treatment if archival tissue not available
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Life expectancy greater than or equal to 12 weeks as judged by the Investigator.
  • Have adequate organ function

Who cannot join

  • A WOCBP who has a positive serum pregnancy test (within 72 hours) prior to treatment.
  • Has received prior investigational agents within 4 weeks prior to treatment.
  • Has received anti-cancer chemotherapy (Immunotherapy (non-antibody-based therapy), retinoid therapy, hormonal therapy within 2 weeks prior to treatment.
  • Has received antibody-based anti-cancer therapy within 4 weeks prior to treatment.
  • Has received targeted agents and small molecules within 2 weeks or 5 half-lives, whichever is longer.
  • Has received prior platinum-based chemotherapy and progressed within 4 weeks of initiating therapy (platinum-refractory disease)
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  • Has received an ADC with MMAE payload.
  • Has received prior radiotherapy within 2 weeks of start of study treatment for focal radiation or within 4 weeks for wide-field radiotherapy
  • Has received G-CSF or GM-CSF within 7 days prior to start of study treatment.
  • Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active CNS metastases and/or carcinomatous meningitis
  • Has severe hypersensitivity (≥ Grade 3), known allergy or reaction LNCB74 or any of its excipients.
  • Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
  • Has active ≥Grade 2 sensory or motor neuropathy.
  • Has active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy or any clinically significant corneal disease.
  • Has an active infection requiring systemic therapy.
  • Any major surgery within 4 weeks of study drug administration.
  • Toxicity (except for alopecia) related to prior anti-cancer therapy and/or surgery, unless the toxicity is either resolved, returned to baseline or Grade 1, or deemed irreversible.
  • Prior organ or tissue allograft.
  • Uncontrolled or significant cardiovascular disease
  • Participants with serious or uncontrolled medical disorders.
  • Participants who are on total parenteral nutrition (TPN)
  • Participants with history of bowel obstruction within one month of screening
  • Participants with history of significant ascites requiring paracentesis within 2 weeks of screening
  • Has a known history of human immunodeficiency virus (HIV) infection with an acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within the last year, or a current CD4 count <350 cells/µl
  • Has known active Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

David Browning contact

615-975-7776

clinicaltrials@ligachembio.com

17 sites in 1 country

United States17 sites, 15 recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Joyce Liu, MD, 877-338-7425, Joyce_Liu@DFCI.HARVARD.EDU

    Joyce Liu, MD

    Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14203

    Roswell Park Information, 800-767-9355, Askroswell@rosewellpark.org

    Emese Zsiros, MD

    Recruiting

  • Cleveland Clinic Taussig Cancer Institute

    Cleveland, Ohio, 44195

    Cancer Group, 866-223-8100, TaussigResearch@ccf.org

    Wen Wee Ma, MD

    Recruiting

  • St. Elizabeth Healthcare

    Edgewood, Kentucky, 41017

    Sara McCauley, (859) 301-4245, Sara.McCauley@stelizabeth.com

    Daniel Flora, MD

    Recruiting

  • Inova Schar Cancer Institute

    Falls Church, Virginia, 22031

    Raymond Wadlow, MD, 571-472-4724, Raymond.Wadlow@inova.org

    Raymond Wadlow, MD

    Recruiting

  • John Theurer Cancer Ctr at Hackensack Univ. Med Ctr.

    Hackensack, New Jersey, 07601

    Oncology Clinical Research Office, 551-996-1777, oncologyresearchreferral@hmhn.org

    Martin Gutierrez

    Not yet recruiting

  • MD Anderson

    Houston, Texas, 77030

    Jing Peng, 713-792-2208, jingpeng@mdanderson.org

    Siqing Fu, MD

    Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

    Erika Hamilton, MD

    Recruiting

  • Mount Sinai Tisch Cancer Center

    New York, New York, 10011

    Dmitriy Zamarin, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Nicholas Mai, MD

    Recruiting

  • Hoag Family Cancer Institute

    Newport Beach, California, 92663

    Completed

  • Sidney Kimmel Comprehensive Center at Jefferson

    Philadelphia, Pennsylvania, 19107

    Phase 1 Unit, 215-586-0199, askphase1@jefferson.edu

    Ida Micaily, MD

    Recruiting

  • UPMC

    Pittsburgh, Pennsylvania, 15213

    Julie Urban, 412-623-7396, urbanj2@upmc.edu

    Julia Foldi, MD

    Recruiting

  • Intermountain/LDS Hospital Ph 1 Research Program

    Salt Lake City, Utah, 84143

    Joshua Kunz, 801-408-4724, joshua.kunz@imail.org

    Caroline Nebhan

    Recruiting

  • NEXT Oncology

    San Antonio, Texas, 78229

    Completed

  • UT Health San Antonio - MD Anderson Cancer Center

    San Antonio, Texas, 78229

    Epp Goodwin, 210-450-5798, goodwine@uthscsa.edu

    Daruka Mahadevan

    Recruiting

  • Washington University, Siteman Cancer Center

    St Louis, Missouri, 63108

    Siteman Cancer Inst. Information, 314-747-1171, MedicalOncologyCallCenter@dom.wustl.edu

    Dan Morgansztern, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Dose Escalation and Dose Expansion Study for LNCB74, a B7-H4 Targeted Antibody Drug Conjugate, as Monotherapy in Participants With Advanced Solid Tumors

This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and / or recommended phase 2 dose of LNCB74 in participants with advanced solid tumors.

Being tested
LNCB74
Keywords
Adenoid Cystic Carcinoma
Medical subject headings
Ovarian Neoplasms, Breast Neoplasms, Endometrial Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Adenoid Cystic

What participants receive

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

  • LNCB74Drug

    LNCB74 is an antibody drug conjugate being evaluated as a potential treatment for participants with advanced solid tumors. Participants will receive LNCB74 into the vein (IV; intravenously) in 21-day dosing cycles. Participants will continue treatment in the absence of unacceptable toxicities and unequivocal disease progression.

Study groups in NCT06774963
Study groupRoleWhat they receive
Part 1 - Dose Escalation and BackfillsExperimentalAim: Doses of LNCB74 will be escalated to determine the maximum tolerated dose (MTD), maximum administered dose (MAD) and/or recommended Phase 2 dose (RP2D). One or more dose levels will be backfilled for safety and additional biomarker data.
Receives: Drug: LNCB74
Part 2 - Dose Expansion / OptimizationExperimentalAim: The objectives of the Part 2 Dose Expansion/Optimization are: i) to evaluate safety, tolerability, anti-tumor activity, and pharmacodynamics of LNCB74 in a more homogenous population and ii) characterize the minimally safe and effective dose in a particular tumor type and determine recommended Phase 2 dose(s) (RP2D).
Receives: Drug: LNCB74

What is being measured

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

  1. Evaluate the safety and tolerability of LNCB74

    Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation and death, and laboratory abnormalities per NCI CTCAE v5.0

    Measured: 24 months

  2. Define a recommended Phase 2 dose (RP2D) of LNCB74

    Maximum tolerated dose (MTD), maximum administered dose (MAD) and/or recommended Phase 2 dose (RP2D) of LNCB74

    Measured: Up to 24 months

Secondary outcomes (14)

  1. Characterize the immunogenicity of LNCB74

    Incidence of anti-drug antibodies to LNCB74

    Measured: 24 months

  2. Objective Response Rate (ORR)

    Objective Response Rate (ORR) per RECIST v1.1

    Measured: 24 months

  3. Duration of Response (DOR)

    Duration of response per RECIST v1.1

    Measured: 24 months

  4. Disease Control Rate (DCR)

    Disease control rate per RECIST v1.1

    Measured: 24 months

  5. Progression Free Survival Rate (PFSR)

    Progression Free Survival Rate per RECIST v1.1

    Measured: 6 months

  6. Correlate B7-H4 Expression with Objective Response Rate (ORR)

    To determine B7-H4 expression by immunohistochemistry in a central lab and correlate B7-H4 expression with Objective Response Rate (ORR)

    Measured: 24 months

  7. Correlate B7-H4 Expression with Duration of Response (DOR)

    To determine B7-H4 expression by immunohistochemistry in a central lab and correlate B7-H4 expression with Duration of Response (DOR)

    Measured: 24 months

  8. Correlate B7-H4 Expression with Disease Control Rate (DCR)

    To determine B7-H4 expression by immunohistochemistry in a central lab and correlate B7-H4 expression with Disease Control Rate (DCR)

    Measured: 24 months

  9. Correlate B7-H4 Expression with Progression Free Survival (PFS)

    To determine B7-H4 expression by immunohistochemistry in a central lab and correlate B7-H4 expression with Progression Free Survival (PFS)

    Measured: 24 months

  10. Progression Free Survival (PFS)

    Progression Free Survival per RECIST v1.1

    Measured: 24 months

  11. Time to Peak Drug Concentration (Tmax) of LNCB74

    To evaluate the Time to Peak Drug Concentration (Tmax) of LNCB74

    Measured: Cycle 1 Days 1, 3, 8 and 15; Cycle 3 Days 1, 3, 8 and 15; Day 1 of Cycles 2, 4, 5, 7 and 9

  12. Area Under the Curve (AUC) of LNCB74

    To evaluate the Area Under the Curve (AUC) of LNCB74

    Measured: Cycle 1 Days 1, 3, 8 and 15; Cycle 3 Days 1, 3, 8 and 15; Day 1 of Cycles 2, 4, 5, 7 and 9

  13. Half-life (T1/2) of LNCB74

    To evaluate the Half-life (T1/2) of LNCB74

    Measured: Cycle 1 Days 1, 3, 8 and 15; Cycle 3 Days 1, 3, 8 and 15; Day 1 of Cycles 2, 4, 5, 7 and 9

  14. Maximum Serum Concentration (Cmax) of LNCB74

    To evaluate the Maximum Serum Concentration (Cmax) of LNCB74

    Measured: Cycle 1 Days 1, 3, 8 and 15; Cycle 3 Days 1, 3, 8 and 15; Day 1 of Cycles 2, 4, 5, 7 and 9

Timeline

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

  1. First posted14 Jan 2025
  2. Study start7 Jan 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

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
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
145 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06774963
Sponsor's protocol ID
LNCB74-01
Other IDs
168703
Acronym
LNCB74-01
Status last verified
Oct 2026
First submitted
8 Jan 2025
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LNCB74 in people with Ovarian Cancer and Breast Cancer, run by LigaChem Biosciences, Inc. at 17 sites in United States.

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 11 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact David Browning (615-975-7776, clinicaltrials@ligachembio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the safety and tolerability of LNCB74 (time frame: 24 months). The study lists 2 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 NCT06774963.

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 29 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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