KK2269 + Docetaxel for Solid Tumors

Recruiting at 5 trial locations

Overseen By Kyowa Kirin, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kyowa Kirin Co., Ltd.

Must be taking: Docetaxel

Disqualifiers: CNS metastasis, Autoimmune disease, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

71 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study. Participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in Part 1. In Part 1, the primary objective is to assess the safety and tolerability of KK2269. In Part 2, only participants with gastric adenocarcinoma, GEJ adenocarcinoma, esophageal adenocarcinoma, or NSCLC who have experienced at least one systemic therapy will be enrolled. In Part 2, the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel and to determine the recommended dose(s) and dose interval(s) of KK2269 in combination with docetaxel for subsequent studies. In both Part 1 and Part 2, participants who refuse to undergo standard therapy are also eligible.

Do I have to stop taking my current medications for the trial?

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.

What safety information is available for the combination of KK2269 and Docetaxel in treating solid tumors?

Docetaxel, a drug used in cancer treatment, can cause side effects like neutropenia (low white blood cell count), skin reactions, and fluid retention. These side effects can often be managed with premedication, such as corticosteroids, to reduce hypersensitivity and other reactions. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Docetaxel for solid tumors?

Docetaxel has been shown to improve survival and quality of life in various cancers, including breast, lung, and prostate cancer, when used alone or in combination with other treatments. It works by stopping cancer cells from dividing, which can slow or stop tumor growth. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Adults over 18 with certain advanced solid tumors (like stomach, esophageal cancer, or non-small cell lung cancer) that can be measured and have no standard therapy left. They must be in relatively good health (ECOG PS of 0 or 1), expected to live at least three more months, and agree to use contraception.

Inclusion Criteria

Patients who have disease measurable by RECIST v1.1

I have a certain type of cancer and can be treated with docetaxel.

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

Exclusion Criteria

Patients with a history of autoimmune disease

Patients with a history of HIV, HBV, or HCV at screening

I have active cancer spread to my brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive KK2269 monotherapy to assess safety and tolerability

8-12 weeks

Regular visits for dose-escalation monitoring

Treatment Part 2

Participants receive KK2269 in combination with docetaxel to assess safety and tolerability

8-12 weeks

Regular visits for combination therapy monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Docetaxel
• KK2269

Trial Overview KK2269 is a new drug being tested for safety and the right dose when given alone or with docetaxel to people with specific cancers. Part 1 tests KK2269 alone; Part 2 combines it with docetaxel in patients who've had prior treatment.

How Is the Trial Designed?

Group I: Part 2 Experimental Treatment 2 Interventions

KK2269 will be administered at each dose level intravenously in combination with docetaxel. Docetaxel will be administered intravenously (Q3W).

Group II: Part 1 Experimental Treatment 1 Intervention

KK2269 will be administered at each dose level, intravenous infusion.

Who Is Running the Clinical Trial?

Kyowa Kirin Co., Ltd.

Lead Sponsor

Trials

181

Recruited

28,800+

Takeyoshi Yamashita

Kyowa Kirin Co., Ltd.

Chief Medical Officer since 2024

Not available

Masashi Miyamoto

Kyowa Kirin Co., Ltd.

Chief Executive Officer

PhD in Molecular Biology

Kyowa Kirin, Inc.

Industry Sponsor

Trials

49

Recruited

5,700+

Published Research Related to This Trial

Docetaxel, a semisynthetic taxane, effectively stabilizes microtubules to induce cell-cycle arrest and apoptosis, showing improved survival rates in various cancers, including metastatic breast cancer and non-small-cell lung cancer.

Randomized trials have demonstrated that adding docetaxel to standard treatments enhances survival outcomes in high-risk early breast cancer and metastatic prostate cancer, highlighting its efficacy across multiple solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel for treatment of solid tumours: a systematic review of clinical data. Montero, A., Fossella, F., Hortobagyi, G., et al.[2022]

Docetaxel has shown high efficacy in treating various tumors, making it a valuable chemotherapeutic option.

The review highlights the safety and efficacy of combining docetaxel with novel targeted biological therapeutics, suggesting that these combinations may enhance treatment outcomes in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the combination of docetaxel (Taxotere) with targeted therapies in the treatment of solid malignancies. Chiuri, VE., Silvestris, N., Lorusso, V., et al.[2019]

Docetaxel is an effective chemotherapy drug that works by binding to microtubules, leading to cell-cycle arrest and apoptosis, and is approved for various cancers including breast, lung, prostate, and recently advanced gastric cancer.

While docetaxel can cause severe neutropenia as a major side effect, alternative dosing schedules have been developed to reduce this toxicity, making it safer for patients with compromised bone marrow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel: a tubulin-stabilizing agent approved for the management of several solid tumors. Ramaswamy, B., Puhalla, S.[2018]

Docetaxel is an effective treatment for non-small cell lung cancer (NSCLC), showing comparable efficacy to newer platinum-based therapies in advanced stages, and has been approved for use in this context.

Clinical trials are ongoing to explore the best ways to combine docetaxel with other treatments, such as thoracic radiotherapy and molecularly targeted agents, to enhance its effectiveness in various stages of NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel in non-small cell lung cancer: a review. Davies, AM., Lara, PN., Mack, PC., et al.[2019]

In a study involving 527 patients with advanced breast cancer, higher doses of docetaxel (60, 75, or 100 mg/m2) were significantly associated with better tumor response rates and improved time to progression, indicating that increasing the dose can enhance treatment efficacy.

However, higher doses also led to increased toxicity, with severe neutropenia occurring in a significant percentage of patients, suggesting that while higher doses may be more effective, they also come with greater risks of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer. Harvey, V., Mouridsen, H., Semiglazov, V., et al.[2022]

Docetaxel has shown significant efficacy in treating advanced breast cancer, with a response rate of up to 73% in phase II trials for first-line therapy and 38% for second-line therapy, particularly effective in patients resistant to anthracyclines (55% response rate).

While neutropenia is the main side effect limiting its dosage, other adverse effects are rare and manageable with premedication, making docetaxel a promising option for advanced breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of phase II studies of docetaxel in patients with metastatic breast cancer. Eisenhauer, EA., Trudeau, M.[2019]

Docetaxel is a highly effective cytotoxic agent that significantly reduces tumor cell survival in vitro and shows strong activity against murine and human tumors in vivo, with over 80% of murine tumors responding positively and complete regression observed in advanced stages.

While docetaxel demonstrates promising efficacy, it also has notable toxic effects, particularly in dogs, leading to hematological, gastrointestinal, and neuromotor toxicity, indicating the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical pharmacology of docetaxel. Bissery, MC.[2019]

Docetaxel is a powerful antitumor drug that works by promoting the formation of microtubules and preventing their breakdown, which stops cancer cells from replicating; it has shown strong effectiveness against various cancers, especially advanced breast cancer and other solid tumors.

While docetaxel can cause side effects like neutropenia (low white blood cell count) and skin reactions, premedication with corticosteroids can help reduce these issues, making it a promising treatment option currently being tested in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel: a review of its pharmacology and clinical activity. Trudeau, ME.[2018]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Docetaxel for treatment of solid tumours: a systematic review of clinical data. [2022]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the combination of docetaxel (Taxotere) with targeted therapies in the treatment of solid malignancies. [2019]

3. Spain pubmed.ncbi.nlm.nih.gov

Docetaxel: a tubulin-stabilizing agent approved for the management of several solid tumors. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Docetaxel in non-small cell lung cancer: a review. [2019]

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

Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer. [2022]

6. England pubmed.ncbi.nlm.nih.gov

An overview of phase II studies of docetaxel in patients with metastatic breast cancer. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Preclinical pharmacology of docetaxel. [2019]

8. Canada pubmed.ncbi.nlm.nih.gov

Docetaxel: a review of its pharmacology and clinical activity. [2018]