280 Participants Needed

PRO1107 for Advanced Cancer

Recruiting at 5 trial locations
PT
GT
Overseen ByGenmab Trial Information
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

What makes the drug PRO1107 unique for treating advanced cancer?

PRO1107 is an antibody-drug conjugate (ADC), which combines the targeting ability of a monoclonal antibody with the cancer-killing power of a chemotherapy drug. This design allows it to specifically target cancer cells, potentially reducing side effects compared to traditional chemotherapy.12345

What is the purpose of this trial?

This is a global, open-label, multicenter Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of GEN1107 (PRO1107) in participants with advanced solid tumors. This study consists of 2 parts, Part A: dose escalation and dose level expansion, and Part B: tumor specific expansion.

Research Team

SO

Study Official

Principal Investigator

Genmab

Eligibility Criteria

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

I have been diagnosed with stomach or gastroesophageal junction cancer.
My breast cancer is triple negative.
I have been diagnosed with non-small cell lung cancer.
See 17 more

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.
See 5 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: GEN1107Experimental Treatment1 Intervention
GEN1107 monotherapy in escalating doses in Part A and at the dose level in Part B.

Find a Clinic Near You

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

Findings from Research

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.
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.
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.
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]

References

Antibody-drug conjugates: Resurgent anticancer agents with multi-targeted therapeutic potential. [2022]
Effects of tumor necrosis factor-related apoptosis-inducing ligand alone and in combination with chemotherapeutic agents on patients' colon tumors grown in SCID mice. [2018]
Phase 1 study of PSMA ADC, an antibody-drug conjugate targeting prostate-specific membrane antigen, in chemotherapy-refractory prostate cancer. [2021]
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. [2021]
Tumor necrosis factor-related apoptosis-inducing ligand's antitumor activity in vivo is enhanced by the chemotherapeutic agent CPT-11. [2018]
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