TUB-040 for Ovarian and Lung Cancers

(NAPISTAR1-01 Trial)

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Tubulis GmbH

Must not be taking: Topoisomerase-I inhibitors

Disqualifiers: Pregnancy, CNS disease, ILD, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this multicentric, open label trial (NAPISTAR 1-01) is to evaluate the safety/tolerability, pharmacokinetics and preliminary efficacy of TUB-040 and to find the best dose of TUB-040 in patients with ovarian cancer and Non Small Cell Lung Cancer. TUB-040 is an antibody-drug-conjugate which delivers a topoisomerase I inhibitor to tumor cells which overexpress the target NaPi2b. The study consists of two parts: In dose escalation, ovarian cancer patients and lung cancer patients receive increasing doses of TUB-040 until the maximal tolerated dose is found. In dose optimization, at least two doses are compared with each other to determine which dose is optimal for patients. TUB-040 is given IV every 3 weeks until the disease progresses or the patient has to stop due to side effects.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently on chemotherapy, radiotherapy, immunotherapy, or corticoid therapy. It's best to discuss your specific medications with the trial team.

What safety data exists for TUB-040 in humans?

The safety data for taxanes, a class of drugs that includes paclitaxel and docetaxel, shows that they can cause side effects like hypersensitivity (allergic reactions), leukopenia (low white blood cell count), neurotoxicity (nerve damage), and alopecia (hair loss). Premedication can reduce severe allergic reactions. In some studies, patients experienced significant neutropenia (low levels of a type of white blood cell) with certain dosing schedules.

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Eligibility Criteria

This trial is for patients with ovarian cancer or recurrent/refractory adenocarcinoma non-small cell lung cancer. Participants must have a tumor that overexpresses NaPi2b and can receive intravenous treatments every 3 weeks. Specific eligibility details are not provided, but typically include factors like age, health status, and prior treatments.

Inclusion Criteria

My organs are working well.

Have a life expectancy of more than 12 weeks for disease-related mortality, as evaluated by the INV

I am an adult over 18, not pregnant or breastfeeding.

Exclusion Criteria

I am allergic to exatecan or ingredients in TUB-040.

I have had nephrotic syndrome in the past.

I have spinal cord compression or active brain disease.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Ovarian cancer and lung cancer patients receive increasing doses of TUB-040 until the maximal tolerated dose is found

Variable, until maximal tolerated dose is found

Every 3 weeks

Dose Optimization

At least two doses are compared to determine the optimal dose for patients

Variable, based on dose comparison

Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study tests TUB-040, an antibody-drug-conjugate targeting NaPi2b to deliver a topoisomerase I inhibitor directly to cancer cells. It's given IV every 3 weeks in two phases: finding the highest dose patients can tolerate (dose escalation) and then determining the best dose (dose optimization).

Group I: Platinum resistant ovarian cancer Experimental Treatment 1 Intervention

Group II: Non small cell lung cancer-adenocarcinoma Experimental Treatment 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Next Oncology Dallas Irving, TX

Next Oncology Virginia Fairfax, VA

OU Health Stephenson Cancer Center Oklahoma City, OK

Christ Hospital Cincinnati, OH

Who Is Running the Clinical Trial?

Tubulis GmbH Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Options for primary chemotherapy of epithelial ovarian cancer: taxanes. [2018] The taxanes, a new class of anticancer agents, act by promoting the assembly of microtubules and stabilizing formed tubules. Two taxanes, paclitaxel and docetaxel, have clinical activity in epithelial ovarian carcinomas, including tumors with platinum resistance. Toxicities associated with the taxanes include hypersensitivity, leukopenia, neurotoxicity, and alopecia. Premedication with dexamethasone, diphenhydramine, and cimetidine decreases the incidence of severe anaphylactic reactions to less than 3%. In Phase II studies, response rates to paclitaxel in patients with previously treated ovarian cancer ranged from 20 to 48%. To date, only two Phase III study using paclitaxel in the treatment of ovarian cancer have mature data. In one trial in patients with suboptimally debulked stage III and IV ovarian cancer, conducted by the Gynecologic Oncology Group, patients receiving paclitaxel/cisplatin had a significantly greater clinical response rate and surgical response rate and a significantly smaller risk of progression than those of patients receiving cisplatin/cyclophosphamide. In a Phase III study of paclitaxel in previously treated patients at two different schedules (3- and 24-hr infusions), conducted by the Canadian-European Taxol Cooperative Group, patients on the 24-hr infusion experienced significantly more grade 4 neutropenia than those receiving the 3-hr infusion. The optimal dose, schedule, and combination for paclitaxel in the treatment of patients with ovarian cancer have not yet been defined. In Phase II studies of docetaxel in patients with previously treated ovarian cancer, response rates of 33-35% were noted. Peripheral edema was noted to be a clinically significant toxicity.

2. United States pubmed.ncbi.nlm.nih.gov

A phase II study of weekly topotecan and docetaxel in heavily treated patients with recurrent uterine and ovarian cancers. [2021] A phase II trial designed to evaluate the safety and efficacy of weekly topotecan and docetaxel in heavily treated patients with recurrent uterine or epithelial ovarian cancers.

3. United States pubmed.ncbi.nlm.nih.gov

A phase I study with an expanded cohort to assess the feasibility of intravenous paclitaxel, intraperitoneal carboplatin and intraperitoneal paclitaxel in patients with untreated ovarian, fallopian tube or primary peritoneal carcinoma: a Gynecologic Oncology Group study. [2021] To define the maximum tolerated dose (MTD) and assess the feasibility of intravenous (IV) paclitaxel, intraperitoneal (IP) carboplatin, and IP paclitaxel in women with newly diagnosed Stages II-IV ovarian, fallopian tube, or primary peritoneal carcinoma.

4. United States pubmed.ncbi.nlm.nih.gov

A phase I study with an expanded cohort to assess feasibility of intravenous docetaxel, intraperitoneal carboplatin and intraperitoneal paclitaxel in patients with previously untreated ovarian, fallopian tube or primary peritoneal carcinoma: a Gynecologic Oncology Group study. [2021] To define the maximum tolerated dose (MTD) and assess the feasibility of intravenous (IV) docetaxel, intraperitoneal (IP) carboplatin and IP paclitaxel in women with stage II-IV untreated ovarian, fallopian tube or primary peritoneal carcinoma.

5. China pubmed.ncbi.nlm.nih.gov

[Clinical study of topotecan in the treatment of small cell lung cancer and recurrent ovarian cancer]. [2013] To evaluate the effect and adverse reaction of China made topotecan in the treatment of small-cell lung cancer (ACLC) and recurrent ovarian cancer (OV).