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Clinical Trials List

Protocol NumberM19-345
NCT Number(ClinicalTrials.gov Identfier)NCT03821935
Active

2020-07-01 - 2027-07-31

Phase I

Recruiting6

ICD-10C18.9

Malignant neoplasm of colon, unspecified

ICD-10C7A.029

Malignant carcinoid tumor of the large intestine, unspecified portion

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9153.9

Malignant neoplasm of colon, unspecified

A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination With ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors

  • Trial Applicant

    AbbVie

  • Sponsor

    AbbVie

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chang-Fang Chiu Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Mu-Hsin Chang 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jaw-Yuan Wang Division of Colorectal Surgery
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Po-Jung Su Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Li Su Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Locally Advanced or Metastatic Solid Tumors

Objectives

The study will determine the recommended Phase 2 dose (RP2D) of ABBV-151 administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-151 alone and in combination with budigalimab. The study will consist of 2 phases: dose escalation and dose expansion.

Test Drug

ABBV-151

Active Ingredient

ABBV-151
Budigalimab (ABBV-181)

Dosage Form

Solution for Infusion
Powder for Solution for Infusion

Dosage

200 mg/10 mL (20 mg/mL)
100 mg/Vial(mg/mL)

Endpoints

Primary Outcome Measures :
Dose Escalation: Recommended Phase 2 Dose (RP2D) ABBV-151 Monotherapy [ Time Frame: Up to 28 days after the first dose of ABBV-151 monotherapy ]
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation portion of the study.

Dose Escalation: RP2D ABBV-151 + Budigalimab Combination Therapy [ Time Frame: Up to 28 days after the first dose of ABBV-151 and ABBV-181 combination therapy ]
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamic (PD) data collected during the dose escalation portion of the study.

Dose Expansion: Objective Response Rate (ORR) [ Time Frame: Up to approximately 6 months after the first dose date of last participant in Dose Expansion ]
ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Inclution Criteria

Inclusion Criteria:

For Dose Escalation only: Participants with an advanced solid tumor who are considered refractory to or intolerant of all existing therapy(ies) known to provide a clinical benefit for their condition. Additionally, participants who have been offered standard therapies and refused, or who are considered ineligible for standard therapies, may be eligible for this study on a case-by-case basis, after discussion with and agreement from the sponsor. Participants with triple-negative breast cancer (TNBC), pancreatic adenocarcinoma, urothelial cancer, Hepatocellular carcinoma (HCC), or Head and neck squamous cell carcinoma (HNSCC) who are being considered for the dose escalation cohorts must also meet the histology specific eligibility criteria described below for dose expansion
For Dose Expansion only participants must meet criteria specific to the type of cancer:
TNBC - Female or male participants with confirmed breast adenocarcinoma that is ER-negative, PR-negative, and HER2-negative, (as defined per American Society of Clinical Oncology [ASCO]/College of American Pathology [CAP] guidelines), who must have disease progression during or after at least 1 systemic therapy that included a taxane in the metastatic or recurrent setting.
Pancreatic adenocarcinoma and have disease progression during or after 1 systemic therapy (gemcitabine monotherapy or in combination with other agents, FOLFIRINOX [or another regimen including both 5-fluorouracil and oxaliplatin], capecitabine monotherapy or in combination with other agents) administered in the adjuvant, locally advanced, or metastatic setting. If the therapy was used in an adjuvant setting, disease progression must have occurred within 6 months of completing adjuvant therapy.
Urothelial cancer of the bladder and urinary tract and must have progressed following treatment with a platinum-based regimen (administered in any line of therapy) and a programmed death 1/programmed death ligand 1 (PD1/PDL1) antagonist administered in the recurrent or metastatic setting (progression following a PD1/PDL1 antagonist is defined as unequivocal progression on or within 3 months of the last dose of anti-PD1 or anti-PDL1 therapy).
HCC and must have disease progression during or after 1 prior line of systemic therapy.
HNSCC (arising from the oral cavity, oropharynx, hypopharynx, or larynx) and must have progressed following treatment with platinum-based regimen (administered in any line of therapy) and a PD1/PDL1 antagonist administered in the recurrent or metastatic setting (progression following a PD1/PDL1 antagonist is defined as unequivocal progression on or within 3 months of the last dose of anti-PD1 or anti-PDL1 therapy).
Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Participant has adequate bone marrow, renal, hepatic, and coagulation function. Must have a viral status consistent with the requirements described in the protocol specific to type of cancer and stage of study (Dose Escalation or Dose Expansion).

Exclusion Criteria

Exclusion Criteria:

For Dose Expansion only: Participants (except for participants with urothelial cancer or HNSCC) who have had prior exposure to immunotherapies as listed in the protocol.
Has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy within a period of 5 half-lives or 28 days (whichever is shorter), prior to the first dose of the study drug.
Participant has unresolved AEs > Grade 1 from prior anticancer therapy except for alopecia.
Has a history of primary immunodeficiency, bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
Has a known uncontrolled metastases to the central nervous system (with certain exceptions).
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of the study drug.

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    362 participants

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