BA3182 for Cancer

Recruiting at 8 trial locations

Overseen By BioAtla Medical Affairs

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BioAtla, Inc.

Disqualifiers: Cardiac disease, CNS metastasis, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

168 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment called BA3182 for individuals with advanced adenocarcinoma, a cancer affecting glands in the body. The trial aims to determine if this treatment can better manage the disease. Participants should have advanced adenocarcinoma that cannot be removed or has spread, along with stable kidney, liver, and blood function. Those with significant heart disease or uncontrolled brain metastases are not eligible. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that BA3182 is likely to be safe for humans?

Research has shown that BA3182 has a safety profile that most patients can handle, meaning it usually doesn't cause severe side effects. In earlier studies, researchers administered BA3182 to 35 patients with advanced adenocarcinoma, a type of cancer. The results were promising, indicating that it might help fight cancer. These findings suggest that BA3182 could be safe for further testing in humans. However, since this is an early-stage trial, researchers are still studying the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

BA3182 is unique because it represents a new approach to treating cancer by targeting specific molecular pathways that current treatments might not address. Unlike traditional chemotherapy, which attacks rapidly dividing cells indiscriminately, BA3182 is designed to home in on cancer cells with more precision, potentially reducing side effects. Researchers are excited about BA3182 because it could offer a more targeted and effective treatment option for patients, potentially improving outcomes and quality of life.

What evidence suggests that BA3182 might be an effective treatment for advanced adenocarcinoma?

In earlier studies, patients taking BA3182 for advanced adenocarcinoma showed promising results. Some patients with colorectal cancer, a type of adenocarcinoma, experienced extended periods without cancer progression. For instance, one patient went 8 months and another 14 months without worsening while on the treatment. BA3182 targets specific proteins on cancer cells, enhancing the immune system's ability to attack the cancer. Although research continues, these early findings suggest that BA3182 might slow the progression of advanced adenocarcinoma. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced adenocarcinoma that can't be removed by surgery or has spread. Participants must have confirmed diagnosis, good kidney and liver function, stable blood counts, and be able to carry out daily activities with minimal symptoms (ECOG status of 0 or 1).

Inclusion Criteria

My cancer is advanced and cannot be removed by surgery.

My liver is working well.

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BA3182 to evaluate safety, tolerability, PK, immunogenicity, and antitumor activity

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BA3182

Trial Overview The study is testing the safety and effectiveness of a new medication called BA3182 in patients who have advanced stages of adenocarcinoma.

How Is the Trial Designed?

Group I: BA3182 Experimental Treatment 1 Intervention

All Patients will receive BA3182

Who Is Running the Clinical Trial?

BioAtla, Inc.

Lead Sponsor

Trials

7

Recruited

1,500+

Published Research Related to This Trial

BAP31 promotes colorectal cancer (CRC) angiogenesis by influencing the tumor microenvironment, specifically through exosomes that transform normal fibroblasts into proangiogenic cancer-associated fibroblasts (CAFs).

The study identified that the microRNA miR-181a-5p, regulated by BAP31, targets the RECK protein, leading to increased levels of matrix metalloproteinase-9 (MMP-9) and activation of Smad2/3, which are crucial for fibroblast transformation and angiogenesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BAP31/miR-181a-5p/RECK axis promotes angiogenesis in colorectal cancer via fibroblast activation. Zhang, Q., Wang, C., Li, R., et al.[2023]

BRCA1- or BRCA2-defective tumors are particularly sensitive to PARP-1 inhibitors, which target alternative DNA repair pathways, but challenges such as acquired resistance and the need for predictive biomarkers remain.

The study identified that defects in the Mre11-Rad50-Nbs1 (MRN) complex can sensitize cancer cells to PARP-1 inhibitors, and suggested that monitoring PARsylation and Rad51 foci formation could serve as potential biomarkers for predicting responses to these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of candidate biomarkers to predict cancer cell sensitivity or resistance to PARP-1 inhibitor treatment. Oplustilova, L., Wolanin, K., Mistrik, M., et al.[2023]

Low expression of the CtIP protein in breast cancer patients is linked to poorer survival rates, indicating its potential role as a prognostic biomarker.

Depleting CtIP in breast cancer cells enhances their sensitivity to PARP inhibitors, suggesting that patients with low CtIP levels may benefit from PARP inhibitor therapies, providing new treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loss of CtIP disturbs homologous recombination repair and sensitizes breast cancer cells to PARP inhibitors. Wang, J., Ding, Q., Fujimori, H., et al.[2020]

PARP inhibitors (PARPi) show a weighted mean objective response rate (ORR) of 45% in patients with advanced breast cancer, with significantly higher efficacy (64%) when combined with platinum-based chemotherapy compared to 37% for PARPi alone.

While PARPi treatment improves progression-free survival compared to standard chemotherapy (HR 0.64), it does not significantly affect overall survival (HR 0.87), and there is no difference in response rates between BRCA1 and BRCA2 mutation carriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations with response to Poly(ADP-ribose) Polymerase (PARP) inhibitors in patients with metastatic breast cancer. Desnoyers, A., Nadler, M., Wilson, BE., et al.[2023]

The combination of CHK1 and PARP1 inhibitors effectively kills various types of breast cancer cells, including estrogen receptor-positive and triple-negative cells, regardless of certain genetic factors.

In animal models, this combination not only suppressed tumor growth but also improved survival rates, suggesting that using both inhibitors together could be a promising strategy for breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poly(ADP-ribose) polymerase 1 modulates the lethality of CHK1 inhibitors in mammary tumors. Tang, Y., Hamed, HA., Poklepovic, A., et al.[2021]

The SADA method identified BAP31 as a novel cancer/testis antigen (CTA) that is significantly upregulated in cervical cancer, particularly in stages I, II, and III, and is associated with poor clinical outcomes.

BAP31 promotes cervical cancer cell proliferation and metastasis by regulating the cell cycle and affecting cytoskeletal dynamics, suggesting that targeting BAP31 could be a potential therapeutic strategy to inhibit cancer progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BAP31, a newly defined cancer/testis antigen, regulates proliferation, migration, and invasion to promote cervical cancer progression. Dang, E., Yang, S., Song, C., et al.[2021]

BAP31 is upregulated in hepatocellular carcinoma (HCC) and is linked to advanced clinical stages, promoting HCC cell proliferation and tumor growth both in vitro and in vivo.

Targeting BAP31 with an anti-BAP31 antibody significantly inhibited tumor growth in HCC models, suggesting that BAP31 could be a promising therapeutic target for treating this aggressive cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BAP31 Promotes Tumor Cell Proliferation by Stabilizing SERPINE2 in Hepatocellular Carcinoma. Zhang, X., Jiang, D., Yang, S., et al.[2020]

B-cell associated protein 31 (BAP31) levels were found to be significantly higher in hepatocellular carcinoma (HCC) tissues compared to non-cancerous tissues, indicating its potential role in cancer progression.

In a study involving 234 patients in a training cohort and 63 in a validation cohort, lower levels of BAP31 expression were correlated with poorer overall survival, establishing it as an independent prognostic factor for HCC outcomes after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low expression of B-cell-associated protein 31 in human primary hepatocellular carcinoma correlates with poor prognosis. Tan, N., Liu, Q., Liu, X., et al.[2022]

ABT-888, a PARP inhibitor, demonstrated a significant reduction of over 95% in intratumor PAR levels after a single dose in a first-in-human clinical trial, indicating its strong efficacy in targeting cancer cells.

The study established effective methodologies for evaluating drug effects in human tumor models, which could guide future clinical trials for targeted cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical modeling of a phase 0 clinical trial: qualification of a pharmacodynamic assay of poly (ADP-ribose) polymerase in tumor biopsies of mouse xenografts. Kinders, RJ., Hollingshead, M., Khin, S., et al.[2019]

BAP31 expression is significantly higher in colorectal cancer (CRC) tissues and liver metastatic CRC tissues compared to normal adjacent mucosa, indicating its potential role in cancer progression.

Low levels of BAP31 expression are associated with poorer overall survival and disease-free survival in CRC patients, suggesting that BAP31 could serve as an independent prognostic marker for patient outcomes after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low expression of B-Cell-Associated protein 31 is associated with unfavorable prognosis in human colorectal cancer. Ma, C., Jin, RM., Chen, KJ., et al.[2018]

Citations

1. ir.bioatla.com ir.bioatla.com/news-releases/news-release-details/bioatla-presents-promising-interim-data-its-phase-1-trial-ba3182

News Release BioAtla continues to advance the ongoing Phase 1 study to evaluate the safety, pharmacokinetics, and efficacy of BA3182 in advanced ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05808634?cond=Cancer&aggFilters=funderType%3Aindustry%2CstudyType%3Aint

Phase 1 Study Evaluating BA3182 in Patients With ... This is a multi-center, open-label, Phase 1 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3182 in ...

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(25)00706-9/fulltext

486P Preliminary results from a first-in-human phase I ... Two pts with CRC experienced prolonged progression-free intervals (8 mo ongoing and 14 mo). Conclusions. BA3182, an EpCAM x CD3 dual-conditionally binding T- ...

4. targetedonc.com targetedonc.com/view/fda-okays-ind-application-of-ba3182-for-advanced-adenocarcinoma

FDA Okays IND Application of BA3182 for Advanced ... The FDA has cleared an investigational new drug (IND) application to evaluate BA3182 for the treatment of patients with advanced adenocarcinoma.

5. ir.bioatla.com ir.bioatla.com/news-releases/news-release-details/bioatla-presents-data-ongoing-dose-escalation-ba3182-dual

News Release Intravenous (IV) formulation of BA3182 was administered to 17 patients at doses of 0.0026 mg to 0.032 mg weekly and the subcutaneous (SC) ...

6. targetedonc.com targetedonc.com/view/bispecific-antibody-yields-safety-antitumor-activity

Novel Bispecific Yields Safety, Activity Across Tumor Types BA3182 showed a manageable safety profile and preliminary antitumor activity in treatment-refractory adenocarcinoma patients, with subcutaneous ...

7. clinicaltrialsarena.com clinicaltrialsarena.com/news/bioatla-ba3182-adenocarcinoma/

BioAtla presents Phase I data of BA3182 for metastatic ... BioAtla has presented first-in-human Phase I study data of its anticancer therapy, BA3182, targeting those with metastatic adenocarcinoma.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05808634

NCT05808634 | Phase 1 Study Evaluating BA3182 in ... This is a multi-center, open-label, Phase 1 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3182 in ...