Solid Tumors Clinical Trial
Official title:
A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-303, as Monotherapy and in Combination With Budigalimab (ABBV-181), in Adult Subjects With Advanced Solid Tumors
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-303 as a monotherapy and in combination with budigalimab, (ABBV-181). ABBV-303 is an investigational drug being developed for the treatment of solid tumors. There are multiple treatment arms in this study. Participants will either receive ABBV-303 as a single agent or in combination with budigalimab (another investigational drug) at different doses. Approximately 181 adult participants will be enrolled in the study across sites worldwide. In Part A, ABBV-303 will be intravenously (IV) infused in escalating doses as a monotherapy in participants with relapsed (R)/refractory (R) solid tumors, R/R non-small cell lung cancer (NSCLC), R/R renal cell carcinoma (RCC), R/R head and neck squamous cell carcinoma (HNSCC), or R/R tissue agnostic participants with mesenchymal epithelial transition. In Part B, ABBV-303 in combination with budigalimab will be IV infused in participants with R/R solid tumors or NSCLC. The estimated duration of the study is up to 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
| Status | Recruiting |
| Enrollment | 192 |
| Est. completion date | January 19, 2028 |
| Est. primary completion date | January 19, 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Laboratory values meeting the protocol's criteria within the screening period (-28 days) prior to the first dose of study drug. - Participants with a diagnosis of a malignant solid tumor by histology (World Health Organization [WHO] criteria). - Participants with measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Exclusion Criteria: - Unresolved Grade > 1 adverse events (AEs) from prior anti-cancer therapy except for alopecia. - Active systemic or uncontrolled local bacterial, fungal, or viral infection requiring antimicrobial therapy. - History of hypersensitivity to the active ingredients or any excipients of ABBV-303 and budigalimab (ABBV-181). - Body weight < 35 kg. |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Rambam Health Care Campus /ID# 254608 | Haifa | H_efa |
| Israel | Hadassah Medical Center-Hebrew University /ID# 254606 | Jerusalem | |
| Israel | The Chaim Sheba Medical Center /ID# 259408 | Ramat Gan | Tel-Aviv |
| Japan | National Cancer Center Hospital /ID# 254359 | Chuo-ku | Tokyo |
| Japan | National Cancer Center Hospital East /ID# 261712 | Kashiwa-shi | Chiba |
| Japan | Shizuoka Cancer Center /ID# 261714 | Sunto-gun | Shizuoka |
| Japan | Wakayama Medical University Hospital /ID# 254361 | Wakayama-shi | Wakayama |
| United States | The Ohio State University - The James /ID# 260475 | Columbus | Ohio |
| United States | City of Hope /ID# 254303 | Duarte | California |
| United States | START Midwest /ID# 256945 | Grand Rapids | Michigan |
| United States | University of Texas MD Anderson Cancer Center /ID# 254308 | Houston | Texas |
| United States | Carolina BioOncology Institute /ID# 254305 | Huntersville | North Carolina |
| United States | City of Hope at Orange County Lennar Foundation Cancer Center /ID# 266792 | Irvine | California |
| United States | University of Southern California /ID# 254356 | Los Angeles | California |
| United States | Washington University-School of Medicine /ID# 262943 | Saint Louis | Missouri |
| United States | NEXT Oncology /ID# 257395 | San Antonio | Texas |
| United States | South Texas Accelerated Research Therapeutics /ID# 256944 | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
United States, Israel, Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events (AE) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to 3 Years | |
| Secondary | Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to RECIST version 1.1. | Up to 3 Years | |
| Secondary | Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1 | DOR is defined for participants achieving a confirmed CR+PR as the time from the initial response of CR+PR per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier. | Up to 3 Years | |
| Secondary | Progression-free survival (PFS) | PFS is defined as time from first study treatment to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier. | Up to 3 Years | |
| Secondary | Overall survival (OS) | OS is defined as time from first study treatment to death due to any cause. | Up to 3 Years | |
| Secondary | ORR per Immune-Mediated Response Evaluation Criteria in Solid Tumors (iRECIST) | ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to iRECIST version 1.1. | Up to 3 Years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT00750841 -
Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours
|
Phase 1 | |
| Withdrawn |
NCT05419817 -
Pembrolizumab With Sitravatinib in Recurrent Endometrial Cancer and Other Solid Tumors With Deficient Mismatch Repair System
|
Phase 2 | |
| Completed |
NCT02828930 -
A Study to Determine the Excretion Balance, Pharmacokinetics, Metabolism and Absolute Oral Bioavailability of a Single Oral Dose of [14C]-Labeled Idasanutlin and an Intravenous Tracer Dose of [13C]-Labeled Idasanutlin in a Single Cohort of Participants With Solid Tumors (Malignancies)
|
Phase 1 | |
| Completed |
NCT01197170 -
Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance
|
Phase 1 | |
| Terminated |
NCT03225105 -
M3541 in Combination With Radiotherapy in Solid Tumors
|
Phase 1 | |
| Completed |
NCT03258515 -
A Study to Investigate the Effect of Single Dose of AZD6094 (600 mg) on Cardiac Repolarization in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
| Completed |
NCT01878890 -
Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure.
|
Phase 1 | |
| Active, not recruiting |
NCT05059522 -
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
|
Phase 3 | |
| Active, not recruiting |
NCT03634982 -
Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04685226 -
A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
| Recruiting |
NCT06036121 -
A Study of ADRX-0706 in Select Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT03258151 -
Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
|
||
| Completed |
NCT01528046 -
Metformin in Children With Relapsed or Refractory Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05325866 -
A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04557449 -
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT02890368 -
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
|
Phase 1 | |
| Completed |
NCT02759640 -
A Phase I Trial of HS-10241 in Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT01940601 -
Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors
|
Phase 2 |