IKS014 for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, IKS014, for individuals with advanced solid tumors, including breast and gastric cancers, that express the HER2 protein. The trial aims to determine the right dose, assess safety, and evaluate effectiveness against tumors. Participants are grouped based on HER2 levels in their cancers. Suitable candidates include those with HER2-positive or HER2-low breast or gastric cancer who have previously tried other treatments. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in humans.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, there is a requirement for an adequate treatment washout period (time without certain treatments) before starting the trial, which includes major surgery and radiation therapy. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that IKS014 is likely to be safe for humans?
Research has shown that IKS014 has promising results in early studies. For HER2-positive cancers, patients have responded to the treatment at various dose levels without severe side effects.
In studies on HER2-low cancers, responses were also positive. Among 11 patients with HER2-low breast cancer who received higher doses, seven responded well. This suggests the treatment is well-tolerated, as these patients did not experience serious side effects.
Overall, these findings are encouraging. They indicate that IKS014 is generally well-tolerated by patients with both HER2-positive and HER2-low cancers. However, since this treatment remains in the early stages of testing, more research is needed to fully understand its safety and effectiveness.12345Why do researchers think this study treatment might be promising for breast cancer?
Unlike the standard of care for HER2-positive breast cancer, which often involves targeted therapies like trastuzumab, pertuzumab, and T-DM1, IKS014 is unique because it offers a novel mechanism of action. While most treatments work by binding to the HER2 receptor to inhibit tumor growth, researchers are excited about IKS014 because it potentially targets the cancer cells more precisely, minimizing damage to healthy cells. This could lead to fewer side effects and improved outcomes. The excitement also stems from its potential application to HER2-positive gastric cancers, broadening its impact across multiple cancer types.
What evidence suggests that IKS014 might be an effective treatment for breast cancer?
Research has shown that IKS014, a new cancer treatment, has delivered promising results in early studies for various cancers, including breast and stomach cancers. In this trial, participants with HER2+ and HER2 low breast cancer will receive IKS014. Early studies revealed that about two-thirds of breast cancer patients treated with IKS014 experienced significant tumor shrinkage. Participants with stomach and gastro-esophageal cancers will also receive IKS014. Previous studies demonstrated that it could shrink tumors at various doses, with some patients experiencing partial tumor shrinkage. These studies suggest that IKS014 could effectively shrink tumors with different levels of HER2, a protein that can promote cancer growth. While these early results are promising, more research is needed to confirm its efficacy.12678
Who Is on the Research Team?
James O'Leary, MD
Principal Investigator
Iksuda Therapeutics
Are You a Good Fit for This Trial?
This trial is for people with advanced solid tumors that are HER2 positive, including certain types of breast, gastric, and gastroesophageal junction cancers. Participants must have tried specific prior treatments if they have hormone receptor-positive breast cancer. They need to meet blood count and organ function criteria but can't join if they've used certain growth factors recently.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive increasing dose levels of IKS014 to establish a recommended phase 2 dose
Dose Expansion
Participants receive IKS014 at the recommended dose to evaluate safety, pharmacokinetics/pharmacodynamics, and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- IKS014
Trial Overview
The study tests IKS014, a drug targeting the HER2 protein on cancer cells. It aims to find the right dose for future studies while checking its safety, how well it works against tumors, any immune response it causes, and how the body processes it.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Each patient will receive IKS014 at the recommended dose defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
Each patient will receive IKS014 at the recommended dose defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
Each patient will receive IKS014 at the recommended dose defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
Each patient will receive IKS014 at the recommended dose defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
Each patient will receive IKS014 at the recommended dose defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
Each patient will receive repeat doses (by intravenous (IV) infusions) on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Iksuda Therapeutics Ltd.
Lead Sponsor
Citations
IKS014 - ADC Programs
IKS014 shows good efficacy across a range of tumors and doses. Phase 1 Part I enrolled patients with a wide range of tumors and a mix of HER2+ and HER2-low ...
Iksuda Presents Encouraging IKS014 Phase 1 Data at ESMO
Amongst 11 participants with breast cancer treated at doses >90mg/m2, seven responses were seen (objective response rate (ORR) 64%), including ...
Iksuda Presents Encouraging IKS014 Phase 1 Data at ESMO
Amongst 11 participants with breast cancer treated at doses >90mg/m2, seven responses were seen (objective response rate (ORR) 64%), including ...
HER2-targeting antibody drug conjugate FS-1502 in HER2 ...
In conclusion, FS-1502 was well tolerated and demonstrated promising antitumor activity in patients with HER2-positive advanced breast cancer.
5.
synapse.patsnap.com
synapse.patsnap.com/article/iksuda-therapeutics-gets-fda-ind-approval-for-iks014Iksuda Therapeutics Gets FDA IND Approval for IKS014
Early results from this study have revealed significant clinical activity across a range of tumor types, such as breast, ovarian, gallbladder, ...
Iksuda Presents Encouraging IKS014 Phase 1 Data at ESMO
IKS014 is a potential best-in-class antibody drug conjugate, benefiting from tumour selective activation and release of the cytotoxic agent ...
ANZCTR - Registration
Experimental: Dose Expansion: HER2 Low Gastric Cancer or Gastro-esophageal Junction Participants - Each patient will receive IKS014 at the ...
HER2-low gastric cancer: is the subgroup targetable? - PMC
Approximately 15%-20% of patients with advanced gastric and gastroesophageal junctional cancers (AGCs) exhibit overexpression or amplification of human ...
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