TUB-040 + Standard Drugs for Ovarian Cancer
(OC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, TUB-040, to evaluate its safety and effectiveness when combined with standard ovarian cancer treatments like carboplatin (a chemotherapy drug) and bevacizumab (an anti-angiogenesis drug). The focus is on high-grade epithelial serous or endometrioid ovarian cancer, particularly in cases responsive to platinum treatments. Researchers aim to determine the optimal dose of TUB-040 that can be safely used with the other drugs. Women with advanced ovarian cancer that has responded to platinum-based therapy and can be measured by scans may be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found TUB-040 to be safe and well-tolerated by patients with ovarian cancer. Most side effects were mild and manageable, with few blood-related issues. Another study confirmed that TUB-040 was well-tolerated at low doses and showed promising results, suggesting its general safety for humans.
Carboplatin, a common drug in cancer treatment, is widely recognized as safe under medical supervision. Research indicates that combining TUB-040 with carboplatin is generally well-tolerated.12345Why do researchers think this study treatment might be promising for ovarian cancer?
Most treatments for ovarian cancer, like carboplatin and bevacizumab, focus on stopping cancer cells from growing by damaging their DNA or cutting off their blood supply. But TUB-040 is unique because it works differently, potentially enhancing the effects of these standard drugs when used together. Researchers are excited about TUB-040 because it might boost the effectiveness of existing treatments, offering a fresh angle in the fight against ovarian cancer. This could mean better outcomes for patients who haven't responded well to current therapies.
What evidence suggests that TUB-040 in combination with standard drugs could be effective for ovarian cancer?
Studies have shown that TUB-040 yields promising results for treating ovarian cancer. In earlier trials, TUB-040 helped up to 67% of patients with platinum-resistant ovarian cancer by shrinking or stopping tumor growth. TUB-040 targets a protein called NaPi2b, present in over 90% of ovarian cancer cases, making it a hopeful treatment option. In this trial, researchers will administer TUB-040 with standard drugs like carboplatin and bevacizumab, as early research suggests that TUB-040 could be effective when combined with these treatments.12345
Who Is on the Research Team?
Tubulis Medical Director
Principal Investigator
Tubulis GmbH
Are You a Good Fit for This Trial?
This trial is for women aged 18 or older with advanced, fast-growing ovarian, fallopian tube, or primary peritoneal cancer that has come back but still responds to platinum-based treatments. Participants need good blood counts and organ function, must be able to perform daily activities well, and have measurable disease.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TUB-040 in combination with carboplatin and bevacizumab to determine safety, tolerability, and maximum tolerated dose
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and response rates
Long-term follow-up
Participants are monitored for overall survival and disease progression
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Carboplatin
- TUB-040
Trial Overview
The study tests a new drug called TUB-040 combined with standard ovarian cancer drugs carboplatin (Carbo) and bevacizumab (BEV). It aims to find the safest dose of TUB-040 when used together with these drugs in patients whose cancer is sensitive to platinum therapy.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Drug TUB-040 administered in combination with carboplatin (Carbo) and bevacizumab (BEV)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tubulis GmbH
Lead Sponsor
Citations
First positive data TUB-040 in ovarian cancer
TUB-040 achieved an Overall Response Rate (ORR) of 59% (cORR 50%), with ORR ranging from 50% to 67% First interim results show clinical proof- ...
2.
cancernetwork.com
cancernetwork.com/view/tub-040-elicits-early-responses-in-platinum-resistant-ovarian-cancerTUB-040 Elicits Early Responses in Platinum-Resistant ...
Data from the NAPISTAR1-01 study showed enduring benefit with TUB-040 among those with platinum-resistant high-grade serous ovarian cancer.
NAPISTAR 1-01: Results of phase 1 dose escalation ...
Conclusions: TUB-040 was well tolerated with promising clinical activity at low doses, offering a potential new treatment option with a ...
4.
onclive.com
onclive.com/view/tub-040-represents-novel-adc-approach-in-platinum-resistant-ovarian-cancerTUB-040 Represents Novel ADC Approach in Platinum ...
Antonio González-Martín, MD, PhD, discusses data for TUB-040 in platinum-resistant ovarian cancer and how it stacks up against other ADCs.
TUB-040, a Homogeneous and Hydrophilic NaPi2b-Targeting ...
Immunohistochemistry (IHC) analysis reveals NaPi2b overexpression in more than 90% of ovarian cancer samples, excluding the mucinous subtype (6, 11, 12).
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