PRO1107 for Advanced Cancer

No longer recruiting at 6 trial locations

Overseen By Genmab Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: ProfoundBio US Co.

Must not be taking: Strong CYP3A inhibitors

Disqualifiers: Other malignancy, Active CNS metastases, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called PRO1107 to evaluate its safety and effectiveness for people with advanced solid tumors, such as certain types of ovarian, endometrial, breast, and lung cancers. Researchers aim to determine the optimal dose and assess its efficacy against these cancers. The trial consists of two parts: one to identify the right dose and another to focus on specific tumor types. Individuals who have tried other treatments without success and have cancers that cannot be surgically removed might be suitable for this study. 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 this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use a strong P450A CYP3A inhibitor within 2 weeks before joining.

Is there any evidence suggesting that PRO1107 is likely to be safe for humans?

Research has shown that PRO1107, a new cancer treatment, is being tested for safety and tolerability. This treatment, an antibody-drug conjugate, targets cancer cells with precision. Although human trials have provided limited information so far, PRO1107 demonstrated strong effects against cancer cells in lab studies.

As the trial is in its early stages, researchers are closely monitoring the treatment's safety. Early trials focus on identifying the safest dose and observing any side effects. So far, available sources have not reported specific safety issues. However, as the trial progresses, more information is expected, and the treatment's full safety profile will become clearer as more participants receive it. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for advanced cancer, which often include chemotherapy and targeted therapies, PRO1107 is a novel approach because it uses an innovative mechanism of action. Most current therapies work by attacking rapidly dividing cells or specific cancer cell markers, but PRO1107 targets a unique pathway that has not been fully exploited before. This new pathway could potentially offer more precise targeting of cancer cells with fewer side effects. Researchers are excited because this could mean more effective treatments with improved quality of life for patients.

What evidence suggests that PRO1107 might be an effective treatment for advanced cancer?

Research has shown that PRO1107, which participants in this trial may receive, exhibits strong effects against tumors in early lab studies. It proved more effective than cofetuzumab pelidotin in animal tests for lung, ovarian, and bladder cancers. PRO1107 targets a protein called PTK7, often found in large amounts on cancer cells. Designed as an antibody-drug conjugate (ADC), it combines a cancer-targeting antibody with a cancer-killing drug. Early studies also suggest that PRO1107 is likely safe, offering hope for treating advanced solid tumors. ^{1 2 6 7 8}

Who Is on the Research Team?

Study Official

Principal Investigator

Genmab

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced solid tumors, including specific types of breast, ovarian, endometrial, gastroesophageal, bladder cancer and non-small cell lung cancer. Participants must have measurable disease after prior treatments and be in good physical condition (ECOG score 0 or 1). They also need to provide a tumor sample.

Inclusion Criteria

My breast cancer is triple negative.

I have been diagnosed with stomach or gastroesophageal junction cancer.

I have been diagnosed with non-small cell lung cancer.

Exclusion Criteria

Additional protocol defined inclusion/exclusion criteria may apply

I haven't taken strong P450A CYP3A inhibitors in the last 2 weeks.

I am positive for HBV, HCV, or HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part A: Evaluation of up to 7 dose levels of PRO1107 on Day 1 of a 21-day cycle by IV infusion

21 days per cycle, multiple cycles

Dose Expansion

Part B: Initiation at a dose level based on analysis from Part A in up to 4 different cohorts

Until disease progression or other stopping criteria

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 18 months

What Are the Treatments Tested in This Trial?

Interventions

• PRO1107

Trial Overview PRO1107 is being tested for safety and effectiveness against various advanced cancers. The study has two parts: Part A to find the right dose and expand it; Part B focuses on specific tumors. It's an open-label trial where everyone knows they're getting PRO1107.

How Is the Trial Designed?

Group I: GEN1107 Experimental Treatment 1 Intervention

GEN1107 monotherapy in escalating doses in Part A and at the dose level in Part B.

Who Is Running the Clinical Trial?

ProfoundBio US Co.

Lead Sponsor

Trials

3

Recruited

750+

Genmab

Lead Sponsor

Trials

76

Recruited

15,300+

Dr. Jan van de Winkel

Genmab

Chief Executive Officer since 2010

PhD in Immunology, University of Utrecht

Dr. Judith Klimovsky

Genmab

Chief Medical Officer since 2019

MD, University of Copenhagen

Published Research Related to This Trial

In a phase Ib/II trial involving 30 patients with recurrent epithelial ovarian cancer, EP0057 combined with paclitaxel showed an overall response rate of 31.6%, including one complete response, indicating potential efficacy in this difficult-to-treat population.

The treatment was well-tolerated, with no dose-limiting toxicities observed, although common side effects included decreased neutrophil count and anemia, highlighting the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase Ib/II and pharmacokinetic study of EP0057 (formerly CRLX101) in combination with weekly paclitaxel in patients with recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Duska, LR., Krasner, CN., O'Malley, DM., et al.[2021]

Antibody-drug conjugates (ADCs) combine the targeting ability of monoclonal antibodies with the cell-killing power of chemotherapy, allowing for more selective treatment of tumors, but they face challenges like low selectivity and potential premature drug release.

Recent advancements in ADC design, such as engineered antibodies that activate only in the tumor environment, aim to enhance their efficacy and safety, leading to the development of next-generation ADCs with improved therapeutic properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibody-drug conjugates: Resurgent anticancer agents with multi-targeted therapeutic potential. Ceci, C., Lacal, PM., Graziani, G.[2022]

TRAIL effectively induces apoptosis in human colon tumors with minimal toxicity to normal cells, demonstrating its potential as a targeted cancer therapy.

Combining TRAIL with chemotherapy agents like 5-fluorouracil (5-FU) or CPT-11 significantly enhances antitumor effects, leading to complete tumor regression in 50% of treated mice, suggesting a promising strategy for colon cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of tumor necrosis factor-related apoptosis-inducing ligand alone and in combination with chemotherapeutic agents on patients' colon tumors grown in SCID mice. Naka, T., Sugamura, K., Hylander, BL., et al.[2018]

In a Phase 1 study involving 52 subjects with treatment-refractory metastatic castration-resistant prostate cancer, PSMA ADC was found to have an acceptable safety profile, with neutropenia and peripheral neuropathy identified as key dose-limiting toxicities.

The study demonstrated promising antitumor activity, with significant reductions in prostate-specific antigen (PSA) and circulating tumor cells (CTCs) observed at doses of 1.8 mg/kg and above, supporting further investigation of PSMA ADC as a treatment option for advanced prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 study of PSMA ADC, an antibody-drug conjugate targeting prostate-specific membrane antigen, in chemotherapy-refractory prostate cancer. Petrylak, DP., Kantoff, P., Vogelzang, NJ., et al.[2021]

Recombinant TRAIL effectively induces tumor regression in mice with human colon carcinoma, showing a dose-dependent inhibition of tumor growth, especially in TRAIL-sensitive tumors.

Combining TRAIL with the chemotherapeutic agent CPT-11 significantly enhances its antitumor activity, leading to greater tumor growth inhibition and higher rates of complete tumor regression, even in initially TRAIL-resistant tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor necrosis factor-related apoptosis-inducing ligand's antitumor activity in vivo is enhanced by the chemotherapeutic agent CPT-11. Gliniak, B., Le, T.[2018]

Citations

1. jitc.bmj.com jitc.bmj.com/content/11/Suppl_1/A1564

1406 A novel PTK7-directed antibody-drug conjugate ... PRO1107 produced potent antitumor effects that were superior to cofetuzumab pelidotin in CDX models representing lung, ovarian, and bladder ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06171789

PRO1107 in Patients With Advanced Solid Tumors This is a global, open-label, multicenter Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of GEN1107 ...

3. synapse.patsnap.com synapse.patsnap.com/article/pro1107-phase-12-trial-begins-targeting-ptk7-with-innovative-adc

PRO1107 Phase 1/2 Trial Begins: Targeting PTK7 with ... PRO1107 is an ADC that targets the Protein Tyrosine Kinase 7 (PTK7) and is linked to ProfoundBio's proprietary hydrophilic MMAE-based linker-drug, LD343.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0169500225003848

A phase 1b study of cofetuzumab pelidotin monotherapy in ... ... (ADC) PRO1107 demonstrated broad antitumor activity with a promising safety profile in preclinical models. J. Immunother. Cancer, 11 (2023), p. 1406, 10.1136 ...

5. ir.genmab.com ir.genmab.com/static-files/8812d624-2941-435c-8bb6-7a3749a4c213

Genmab Interim Report Q2 2025 Rina-S is a novel FRα-targeted TOPO1 ADC being evaluated for the potential treatment of ovarian cancer and other FRα-expressing cancers. Dose ...

6. clinicaltrialsarena.com clinicaltrialsarena.com/news/profoundbio-solid-tumour-trial/

ProfoundBio begins dosing in trial of drug for solid tumours The trial aims to explore PRO1107's tolerability, safety, pharmacokinetics and anti-tumour activity in various forms of cancer, including non- ...

7. clin.larvol.com clin.larvol.com/trial-detail/NCT06171789

PRO1107 in Patients With Advanced Solid Tumors PRO1107, a protein tyrosine kinase 7 (PTK7) targeted ADC, in Phase 1 trials with initial results anticipated in 2025. PRO1286, a bi-specific ADC, anticipated to ...

8. prnewswire.com prnewswire.com/news-releases/profoundbio-announces-first-patient-dosed-in-phase-12-clinical-trial-of-pro1107-a-protein-tyrosine-kinase-7-ptk7-targeted-antibody-drug-conjugate-incorporating-a-novel-proprietary-hydrophilic-mmae-based-linker-drug-302052878.html

ProfoundBio Announces First Patient Dosed in Phase 1/2 ... This trial is designed to determine the safety, tolerability, pharmacokinetics, and antitumor activity of PRO1107 in patients with advanced ...