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Advanced Solid TumorsPhase 1/2NCT05941507

A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors

A Phase 1/2 study testing LCB84 and Anti-PD-1 monoclonal antibody in people with Advanced Solid Tumors, run by LigaChem Biosciences, Inc. at 8 sites in 2 countries.

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 a first-in-human, Phase 1/2 study to evaluate LCB84, a TROP2-directed antibody-drug conjugate, alone and in combination with an anti-PD-1 Ab, in dose escalation (Phase 1) followed by dose expansion (Phase 2). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
LCB84 and Anti-PD-1 monoclonal antibody
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
8 sitesin 2 countries
Study dates
5 Oct 2023to May 2027
Phase
Phase 1/2
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

  • Phase 1 Dose Escalation: histologically or cytologically confirmed advanced solid tumors refractory to standard of care treatment.
  • Phase 2 Dose Expansion*: select histologically or cytologically confirmed advanced solid tumors refractory to standard of care treatment.
  • expansion cohort indications to be prioritized based on data from Phase 1 dose escalation.
  • Prior treatment with TROP2-directed therapy is permitted.
  • Measurable disease as defined by RECIST v1.1 or RANO-BM.
  • Willingness to provide archival tumor tissue when available or to undergo pre-treatment biopsy if not available.
Show all 13Show fewer
  • Mandatory pre- and on-treatment biopsies for enrichment cohorts in Phase 1 dose escalation and Phase 2 expansion cohorts if deemed medically feasible and safe.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function as defined by:
  • Absolute neutrophil count (ANC) ≥1.5 x 109/L (1500/µL), without colony-stimulating factor support for the past 14 days
  • Platelets ≥100.0 x 109/L (100 000/µL)
  • Hemoglobin ≥9.0 g/dL
  • Aspartate aminotransferase (AST) ≤2.5 x ULN; alanine aminotransferase (ALT) ≤2.5 x ULN (AST, ALT ≤5 x ULN if liver metastases present)

Who cannot join

  • Active or progressing central nervous system (CNS) metastases or any evidence of leptomeningeal disease.
  • Note: Patients with stable or treated CNS metastases may be eligible if all of the following criteria are met: 1) localized treatment for brain metastases completed at least 4 weeks prior to the first dose of study drug 2) no new or progressive neurologic symptoms and without need for immediate local therapy, steroids or anticonvulsants for symptom control (stable or decreasing steroid dose (a stable dose of ≤4 mg dexamethasone oral or equivalent) is permitted) 3) stable brain metastases for at least 1 month prior to screening (baseline) brain MRI.
  • Persistent toxicities from previous systemic antineoplastic treatments >Grade 1, excluding alopecia and vitiligo.
  • Systemic antineoplastic therapy (including antiestrogen therapy) within 5 half-lives or 4 weeks, whichever is shorter, prior to first dose of the study drug.
  • Concomitant use of systemic steroids at dose of >10 mg of prednisone or its equivalent per day (exception for brain metastases, as described in exclusion criteria #1 above).

Trial locations and contacts

8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

David Browning contact

+1-615-975-7776

dbrowning@ligachembio.com

8 sites in 2 countries

United States7 sites, 7 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Cancer Answer Line, 1-800-865-1125, CancerAnswerLine@med.umich.edu

    Paul Swiecicki, MD

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

    DFCI External Referral, dfcicctiexternalreferral@dfci.harvard.edu

    Glenn Hanna, MD

    Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

    Douglas Orr, MD, 972-566-3000, dorr@marycrowley.org

    Douglas Orr, MD

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Heather McArthur, M.D.

    Not yet recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Anjali Raina, 713-792-3238, ARaina@mdanderson.org

    Funda Meric-Bernstam, MD

    Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Yuan Yuan, MD

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Jeff Russell, M.D.

    Not yet recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Study Coordinator, 416 946 4501 x 4737, virtuoso@uhn.ca

    Philippe Bedard, MD

    Recruiting

Other trials in Canada

About this study

Official title: A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination With an Anti-PD-1 Ab, in Patients With Advanced Solid Tumors

This is a first-in-human, Phase 1/2 study to evaluate LCB84, a TROP2-directed antibody-drug conjugate, alone and in combination with an anti-PD-1 Ab, in dose escalation (Phase 1) followed by dose expansion (Phase 2).

The study population in dose escalation (Phase 1) consists of patients with advanced solid tumors refractory to standard of care, or for whom no standard of care exists. After the MTD and/or RP2D for single agent LCB84 is determined, dose escalation cohorts with select tumor types will be enrolled. Combination LCB84 and anti-PD-1 Ab will be evaluated in dose escalation after a minimum of 2 dose levels of single agent LCB84 have established DLT safety, to determine the MTD and/or RP2D of combination LCB84 and anti-PD-1 Ab, and to continue into dose expansion cohorts in select tumor types.

Being tested
LCB84, Anti-PD-1 monoclonal antibody
Keywords
TROP2, TROP-2, Breast Cancer, Head and Neck Cancer, TNBC, Gastric Cancer, Gastroesophageal, NSCLC, Lung Cancer, Glioblastoma, Endometrial Cancer, Ovarian Cancer, Cervical Cancer, Anal Cancer, Pancreatic Cancer, Urothelial Cancer, HNSCC, Salivary gland cancer, LCB84
Medical subject headings
Breast Neoplasms, Head and Neck Neoplasms, Stomach Neoplasms, Lung Neoplasms, Glioblastoma, Endometrial Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms

What participants receive

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

  • LCB84Drug

    TROP2-directed human monoclonal antibody (Ab) linked to a monomethyl auristatin E (MMAE) prodrug

  • Anti-PD-1 monoclonal antibodyDrug

    anti-PD-1 Ab

Study groups in NCT05941507
Study groupRoleWhat they receive
LCB84 monotherapyExperimentalIV infusion Q3W
Receives: Drug: LCB84
LCB84 + anti-PD-1ExperimentalIV infusion Q3W
Receives: Drug: LCB84; Drug: Anti-PD-1 monoclonal antibody

What is being measured

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

  1. Safety of LCB84 alone and LCB84 in combination with an anti-PD-1 Ab (Phase 1 and 2)

    Incidence and severity of AEs and SAEs

    Measured: Up to 48 months

  2. Recommended Phase 2 Dose of LCB84 alone and LCB84 in combination with an anti-PD-1 Ab (Phase 1)

    Based on tolerability, preliminary anti tumor activity, and pharmacokinetics

    Measured: Up to 24 months

  3. Objective Response Rate (Phase 2)

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

    Measured: Up to 24 months

  4. Clinical Benefit Rate (Phase 2)

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

    Measured: Up to 24 months

  5. Duration of Response (Phase 2)

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

    Measured: Up to 24 months

  6. Time to Progression (Phase 2)

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

    Measured: Up to 24 months

  7. Progression Free Survival (Phase 2)

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

    Measured: Up to 24 months

  8. Overall Survival (Phase 2)

    Survival rates

    Measured: Up to 24 months

Secondary outcomes (6)

  1. Plasma Concentrations of LCB84 (Phase 1 and 2)

    Pharmacokinetic parameters will be determined from observed concentrations of LCB84

    Measured: Up to 48 months

  2. Evaluation of the immunogenicity of LCB84 (Phase 1 and 2)

    Occurrence of ADA measured in serum at selected timepoints during the study

    Measured: Up to 48 months

  3. Objective Response Rate (Phase 1)

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

    Measured: Up to 24 months

  4. Duration of Response (Phase 1)

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

    Measured: Up to 24 months

  5. Time to Progression (Phase 1)

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

    Measured: Up to 24 months

  6. Progression Free Survival (Phase 1)

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

    Measured: Up to 24 months

Timeline

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

  1. First posted12 Jul 2023
  2. Study start5 Oct 2023
  3. Primary completionJan 2027 (estimated)
  4. Study completionMay 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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05941507
Sponsor's protocol ID
LCB84-1001
Status last verified
Sep 2025
First submitted
4 Jul 2023
Last updated
24 Sep 2025
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 1/2 study testing LCB84 and Anti-PD-1 monoclonal antibody in people with Advanced Solid Tumors, run by LigaChem Biosciences, Inc. at 8 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 13 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: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Canada. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 (+1-615-975-7776, dbrowning@ligachembio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of LCB84 alone and LCB84 in combination with an anti-PD-1 Ab (Phase 1 and 2) (time frame: Up to 48 months). The study lists 8 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 NCT05941507.

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 Sep 2025.

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Clinical Trial NCT05941507 | AzTrials