366 Participants Needed

BLU-222 for Solid Cancers

Recruiting at 22 trial locations
BM
Overseen ByBlueprint Medicines
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Blueprint Medicines Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you must stop all current medications, but you cannot take any prohibited medications or herbal remedies that cannot be stopped at least 2 weeks before starting the study drug.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications, but it mentions that you cannot take certain prohibited medications or herbal remedies within 2 weeks before starting the study drug.

What data supports the idea that BLU-222 for Solid Cancers is an effective drug?

The available research does not provide any specific data on the effectiveness of BLU-222 for Solid Cancers. Instead, it focuses on other treatments for metastatic breast cancer, such as combinations of docetaxel, bevacizumab, and other drugs. Without direct data on BLU-222, we cannot compare its effectiveness to these other treatments.12345

What safety data is available for BLU-222 in solid cancers?

The provided research does not contain any safety data for BLU-222 or its variants. The studies focus on other treatments such as eribulin, paclitaxel, carboplatin, trastuzumab, pertuzumab, and cisplatin, primarily in breast cancer patients. No information on BLU-222 is available in these abstracts.678910

Is the drug BLU-222 a promising treatment for solid cancers?

The drug BLU-222 is considered promising because it targets cancer stem cells, which are responsible for cancer growth and recurrence. By focusing on these cells, BLU-222 has the potential to improve cancer treatment outcomes and reduce the chances of the cancer coming back.1112131415

What is the purpose of this trial?

This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-222, a selective inhibitor of CDK2.

Eligibility Criteria

This trial is for adults with certain advanced solid tumors, including breast cancer, ovarian cancer, endometrial cancer, and stomach cancer that have worsened despite standard treatments. Participants must not be in a health crisis due to their tumor or have serious heart issues or uncontrolled infections. Women of childbearing potential and men must agree to use effective contraception.

Inclusion Criteria

My endometrial or gastric cancer has worsened after 2 treatments, including a platinum-based therapy.
My cancer has worsened despite standard treatments.
My breast cancer is HR+ HER2- and worsened after CDK4/6 inhibitor treatment.
See 1 more

Exclusion Criteria

I don't have lasting side effects from previous treatments.
I do not have serious heart problems like recent heart attacks or uncontrolled high blood pressure.
I do not have any major surgeries planned within 2 weeks of starting the study drug.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BLU-222 as a single agent or in combination with other drugs during dose escalation and expansion phases

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • BLU-222
Trial Overview The study is testing BLU-222's safety and effectiveness against various cancers. It's an early-phase trial where patients will receive BLU-222 alone or combined with other drugs like Carboplatin, Ribociclib, or Fulvestrant to see how well they work together.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: BLU-222 MonotherapyExperimental Treatment2 Interventions
Dose Escalation: Multiple doses for BLU-222 for oral administration Dose Expansion: Oral dose of BLU-222 as determined during Dose Escalation
Group II: BLU-222 + Ribociclib + FulvestrantExperimental Treatment3 Interventions
Dose Escalation: Multiple doses for BLU-222 for oral administration at doses deemed appropriate based on BLU-222 Monotherapy arm along with Ribociclib and Fulvestrant at the approved doses. Dose Expansion: Oral dose of BLU-222 as determined during dose escalation and approved doses of Ribociclib and Fulvestrant
Group III: BLU-222 + FulvestrantExperimental Treatment2 Interventions
Dose Expansion: Oral dose of BLU-222 as determined during Dose Escalation + fulvestrant at the approved dose
Group IV: BLU-222 + CarboplatinExperimental Treatment2 Interventions
Dose Escalation: Multiple doses for BLU-222 for oral administration at doses deemed appropriate based on BLU-222 Monotherapy arm and multiple doses of Carboplatin at the approved dose. Dose Expansion: Oral dose of BLU-222 as determined during Dose Escalation and Carboplatin IV infusion at approved dose

Find a Clinic Near You

Who Is Running the Clinical Trial?

Blueprint Medicines Corporation

Lead Sponsor

Trials
31
Recruited
6,000+

Findings from Research

In a phase II study involving 53 patients with bulky, operable breast cancer, the combination of sequential neoadjuvant docetaxel followed by an anthracycline-based regimen achieved an overall clinical response rate of 81.1%, with 87% of patients able to undergo breast conservation surgery.
While the pathologic complete response rate was lower than hoped, the study demonstrated effective management of myelosuppression through growth factor support, and after 40.4 months of follow-up, only 5 recurrences were noted, indicating promising long-term outcomes.
Sequential addition of an anthracycline-based regimen to docetaxel as neoadjuvant chemotherapy in patients with operable breast cancer.Amat, S., Mouret-Reynier, MA., Penault-Llorca, F., et al.[2018]
In a phase II trial involving 76 patients with HER2/neu-negative metastatic breast cancer, the combination of docetaxel and bevacizumab showed a promising objective response rate of 51%, with a median overall survival of 26.3 months.
The treatment was generally well tolerated, with manageable side effects, although common grade 3/4 adverse events included neutropenia (33%) and leukopenia/lymphopenia (25%).
A phase II trial of docetaxel with bevacizumab as first-line therapy for HER2-negative metastatic breast cancer (TORI B01).Hurvitz, SA., Allen, HJ., Moroose, RL., et al.[2020]
In a phase II trial involving 155 women with metastatic breast cancer, a combination of weekly paclitaxel, 5-fluorouracil, and leucovorin showed an overall response rate of 48% and estimated 12-month survival rates of 53% and 65% for different treatment schedules.
The treatment regimen was well tolerated, even among patients with hepatic dysfunction and those over 65 years old, suggesting it could be a suitable first-line therapy for patients who cannot receive anthracycline-based treatments.
A phase II trial of weekly paclitaxel, 5-fluorouracil, and leucovorin as first-line treatment for metastatic breast cancer.Loesch, DM., Asmar, L., Canfield, VA., et al.[2019]

References

Sequential addition of an anthracycline-based regimen to docetaxel as neoadjuvant chemotherapy in patients with operable breast cancer. [2018]
A phase II trial of docetaxel with bevacizumab as first-line therapy for HER2-negative metastatic breast cancer (TORI B01). [2020]
A phase II trial of weekly paclitaxel, 5-fluorouracil, and leucovorin as first-line treatment for metastatic breast cancer. [2019]
Phase II trial of doxorubicin and docetaxel plus granulocyte colony-stimulating factor in metastatic breast cancer: Eastern Cooperative Oncology Group Study E1196. [2022]
In the end what matters most? A review of clinical endpoints in advanced breast cancer. [2023]
Eribulin efficacy based on type of metastatic site: a real-life study in heavily pretreated metastatic breast cancer. [2017]
Efficacy and safety of eribulin in taxane-refractory patients in the 'real world'. [2017]
Neoadjuvant weekly paclitaxel and carboplatin with trastuzumab and pertuzumab in HER2-positive breast cancer: a Brown University Oncology Research Group (BrUOG) study. [2022]
Clinical efficacy of weekly cisplatin for treatment of patients with breast cancer. [2022]
Economic burden of selected adverse events in patients aged ≥65 years with metastatic renal cell carcinoma. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Simultaneous Targeting of Differentiated Breast Cancer Cells and Breast Cancer Stem Cells by Combination of Docetaxel- and Sulforaphane-Loaded Self-Assembled Poly(D, L-lactide-co-glycolide)/Hyaluronic Acid Block Copolymer-Based Nanoparticles. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Clinical implications of CD44+/CD24- tumor cell ratio in breast cancer. [2017]
The flavonoid apigenin reduces prostate cancer CD44(+) stem cell survival and migration through PI3K/Akt/NF-κB signaling. [2022]
Targeting Breast Cancer Stem Cells to Overcome Treatment Resistance. [2023]
15.United Statespubmed.ncbi.nlm.nih.gov
The therapeutic promise of the cancer stem cell concept. [2023]
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