Breast CancerPhase 1NCT05872295
IKS014 in Advanced Solid Tumors That Express HER2
A Phase 1 study testing IKS014 in people with Breast Cancer and Gastric Cancer, run by Iksuda Therapeutics Ltd. at 13 sites in 4 countries.
Trial summary
This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate, in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Gastric Cancer, Gastroesophageal-junction Cancer
- What is being tested?
- IKS014
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 14 Sep 2023to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HER2 positive solid tumors with expression defined as IHC3+, IHC2+/ISH+, or low HER2 expression defined as IHC2+ (ISH-) or IHC1+ (ISH- /+ or untested).
- Participants with HR positive BC must have received prior treatment with a CDK4/6 inhibitor, in countries where this is standard therapy.
- Platelets ≥ 75,000 /mcL
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count ≥ 1000/mcL
- No administration of granulocyte colony-stimulating factor (G-CSF) is allowed within 2 weeks prior to first study drug administration
Show all 19Show fewer
- Creatinine clearance > 45/mL/min (using the Cockcroft-Gault equation)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3 x institutional upper limit of normal (ULN) ≤ 5 x ULN if liver metastases present
- Total bilirubin ≤ 1.5 x ULN if no liver metastases or < 3 x ULN with Gilbert's Syndrome or liver metastases at baseline
- Albumin > 2.5 g/dL
- Prothrombin time or international normalized ratio (INR) and either partial thromboplastin time (PTT) or activated (a) PTT ≤ 1.5 x ULN, ≤ 3 x institutional ULN if anticoagulated.
- Must have adequate treatment washout period before trial treatment, defined as: Major surgery (≥ 4 weeks) and radiation therapy (≥ 3 weeks; in case of palliative radiation ≥ 2 weeks)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (or equivalent Karnofsky PS)
- Part 2 Dose Expansion Cohorts May Include:
- Advanced or metastatic BC that is confirmed HER2-positive defined as IHC 3+ or IHC 2+ and evidence of HER2 amplification by ISH, as per ASCO-CAP and previously treated with at least two HER2 directed treatments.
- Advanced or metastatic BC that has low HER2 expression defined as IHC2+ (ISH-) or IHC1+ (ISH-/+ or untested) and previously treated with at least 1 prior line of therapy which may include chemotherapy and/or a HER2 directed ADC.
- Advanced or metastatic GC or GEJ cancer that is confirmed HER2-positive defined as IHC 3+ or IHC 2+ and evidence of HER2 amplification by ISH as per ASCO-CAP and previously treated with at least 1 prior line of therapy, which may include chemotherapy and/or a HER2 directed ADC.
- Advanced or metastatic solid tumor that has been treated with standard of care therapy and is HER2 positive (HER2 IHC3+) as per ASCO-CAP or metastatic NSCLC (that has been treated with standard of care therapy) with a known activating HER2 (ERBB2) mutation.
- Advanced or metastatic adenocarcinoma of the Esophagus that has been treated with at least one prior line of standard treatment, which may have included a HER2-directed therapy. The tumor must be HER2 positive defined either HER2 IHC3+ or HER2 IHC 2+/ISH+.
Who cannot join
- History of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
- Any clinically apparent ≥ Grade 2 pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months of the trial enrollment, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis), or prior pneumonectomy.
- Current evidence of ≥ Grade 2 keratitis or other corneal abnormality.
- Evidence of a clinically significant (≥ Grade 2) abnormality on slit-lamp examination or other clinically significant ophthalmologic finding, as determined by an ophthalmologist.
- Evidence of clinically significant (≥ Grade 2) confluent superficial keratitis, a corneal epithelial defect, a corneal ulcer, or stromal opacity.
- Participant must not use contact lenses while participating in this study.
Show all 17Show fewer
- Central nervous system metastatic disease unless treated with definitive local therapy (surgical resection, stereotactic radiotherapy, or whole brain radiotherapy) and participant is clinically, radiologically and neurologically stable for at least 4 weeks prior to the first dose of study drug not on steroid therapy or are on a stable or decreasing dose of steroids for at least 7 days prior to first dose of study drug. Prophylactic anticonvulsant medications are allowed.
- Active second malignancy or history of another malignancy within the last 2 years with the exception of:
- Treated, non-melanoma skin cancers
- Treated carcinoma in situ (CIS) (e.g., breast, cervix)
- Controlled, superficial carcinoma of the urinary bladder
- T1a or b carcinoma of the prostate treated according to local standard of care, with prostate specific antigen (PSA) within normal limits (WNL) for the institution
- Papillary thyroid carcinoma Stage I treated surgically for cure
- Clinically significant cardiovascular disease or condition
- Clinically significant liver disease
- Any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever > 38ºC within 2 weeks prior to first trial drug administration.
- Any other serious, life-threatening, or unstable preexisting medical condition (aside from the underlying malignancy), including significant organ system dysfunction, or clinically significant laboratory abnormality(ies), which, in the opinion of the Investigator, would either compromise the participant's safety or interfere with obtaining informed consent, compliance with trial procedures, or evaluation of the safety of the trial drug.
Trial locations and contacts
13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 4 countries
Australia6 sites, 6 recruiting
- Recruiting
Concord Repatriation General Hospital Medical Oncology Clinical Trials Unit
Concord, New South Wales, 2139
Tam Bui, MD
- Recruiting
Peninsula & South Eastern Haematology and Oncology Group (PSEHOG)
Frankston, Victoria, 3199
Vinod Ganju, MD
- Recruiting
Alfred Health
Melbourne, Victoria, 3004
Malaka Ameratunga, MD
- Recruiting
Linear Clinical Research
Nedlands, Western Australia, 6009
Peter Lau, MD
- Recruiting
Macquarie University
Sydney, New South Wales, 2109
Dhanusha Sabanathan, MD
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Adnan Nagrial, MD
United States4 sites, 4 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Nancy Lin, MD
- Recruiting
START Dallas - Fort Worth
Fort Worth, Texas, 76104
Hope Team, hopeteam@startresearch.com
Henry Xiong, MD
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
Jeffrey Russell, MD
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Monica Mita, MD
Singapore2 sites, 2 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore
Jing Ying Tira Tan, MBBS
- Recruiting
Tan Tock Seng Hospital
Singapore
Yue Ming Valerie Heong, MBBS
New Zealand1 site, 1 recruiting
- Recruiting
Auckland City Hospital
Auckland
Jane So, MBChB
About this study
Official title: A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS014, a HER2-Targeting Antibody Drug Conjugate (ADC), in Participants With Advanced HER2+ Solid Tumors
This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate, in patients with advanced solid tumors.
Read the detailed description
The study will consist of 2 parts: dose-escalation (Part 1) and dose-expansion (Part 2). The dose-escalation part (Part 1) of the study is to evaluate the safety and tolerability of increasing dose levels of IKS014 to establish a recommended phase 2 dose (RP2D); and the dose-expansion part (Part 2) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of IKS014 at the RP2D.
- Being tested
- IKS014
- Keywords
- HER2, IKS014, Low HER2, Advanced tumors, HER2+, HER2-positive, HER2 expression, GEJ
- Medical subject headings
- Breast Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IKS014Drug
IKS014 is a human monoclonal antibody (Ab) targeting HER2 linked to monomethyl auristatin F (MMAF) cytotoxic agent.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort (Part 1) | Experimental | 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. Receives: Drug: IKS014 |
| Dose Expansion: HER2+ Breast Cancer Participants | Experimental | 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. Receives: Drug: IKS014 |
| Dose Expansion: HER2 Low Breast Cancer Participants | Experimental | 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. Receives: Drug: IKS014 |
| Dose Expansion: HER2+ Gastric Cancer or Gastro-esophageal Junction Participants | Experimental | 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. Receives: Drug: IKS014 |
| Dose Expansion: HER2 Low Gastric Cancer or Gastro-esophageal Junction Participants | Experimental | 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. Receives: Drug: IKS014 |
| Dose Expansion: HER2 Solid Tumor Cancer Participants | Experimental | 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. Receives: Drug: IKS014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose (Part 1)
Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics
Measured: Up to 24 months
Objective Response Rate (Part 2)
Anti-tumor activity will be assessed by RECIST 1.1
Measured: Up to 24 months
Secondary outcomes (3)
Objective Response Rate (Part 1)
Anti-tumor activity will be assessed by RECIST 1.1
Measured: Up to 24 months
Plasma Concentrations of IKS014 (Part 1 and 2)
Pharmacokinetic parameters will be determined from observed concentrations of IKS014
Measured: Up to 48 months
Evaluation of the immunogenicity of IKS014 (Part 1 and 2)
Occurrence of ADA measured in serum at selected timepoints during the study
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start14 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iksuda Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James O'Leary, MD, Study director, Iksuda Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872295
- Sponsor's protocol ID
- IKS014-01
- Status last verified
- Sep 2026
- First submitted
- 14 May 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS014, a HER2-Targeting Antibody Drug Conjugate (ADC), in Participants With Advanced HER2+ Solid Tumors
- ClinicalTrials.gov ID
- NCT05872295
- Acronym / sponsor ID
- IKS014-01
- Keywords
- HER2, IKS014, Low HER2, Advanced tumors, HER2+, HER2-positive, HER2 expression, GEJ
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Iksuda Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate, in patients with advanced solid tumors.
Detailed description
The study will consist of 2 parts: dose-escalation (Part 1) and dose-expansion (Part 2). The dose-escalation part (Part 1) of the study is to evaluate the safety and tolerability of increasing dose levels of IKS014 to establish a recommended phase 2 dose (RP2D); and the dose-expansion part (Part 2) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of IKS014 at the RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort (Part 1) | Experimental | Drug: IKS014Each 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. |
| Dose Expansion: HER2+ Breast Cancer Participants | Experimental | Drug: IKS014Each 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. |
| Dose Expansion: HER2 Low Breast Cancer Participants | Experimental | Drug: IKS014Each 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. |
| Dose Expansion: HER2+ Gastric Cancer or Gastro-esophageal Junction Participants | Experimental | Drug: IKS014Each 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. |
| Dose Expansion: HER2 Low Gastric Cancer or Gastro-esophageal Junction Participants | Experimental | Drug: IKS014Each 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. |
| Dose Expansion: HER2 Solid Tumor Cancer Participants | Experimental | Drug: IKS014Each 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- HER2 positive solid tumors with expression defined as IHC3+, IHC2+/ISH+, or low HER2 expression defined as IHC2+ (ISH-) or IHC1+ (ISH- /+ or untested).
- Participants with HR positive BC must have received prior treatment with a CDK4/6 inhibitor, in countries where this is standard therapy.
- Platelets ≥ 75,000 /mcL
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count ≥ 1000/mcL
Key exclusion criteria (17 listed)
- History of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
- Any clinically apparent ≥ Grade 2 pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months of the trial enrollment, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis), or prior pneumonectomy.
- Current evidence of ≥ Grade 2 keratitis or other corneal abnormality.
- Evidence of a clinically significant (≥ Grade 2) abnormality on slit-lamp examination or other clinically significant ophthalmologic finding, as determined by an ophthalmologist.
- Evidence of clinically significant (≥ Grade 2) confluent superficial keratitis, a corneal epithelial defect, a corneal ulcer, or stromal opacity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IKS014IKS014 is a human monoclonal antibody (Ab) targeting HER2 linked to monomethyl auristatin F (MMAF) cytotoxic agent. | Drug | Dose Escalation Cohort (Part 1), Dose Expansion: HER2 Low Breast Cancer Participants, Dose Expansion: HER2 Low Gastric Cancer or Gastro-esophageal Junction Participants, Dose Expansion: HER2 Solid Tumor Cancer Participants, Dose Expansion: HER2+ Breast Cancer Participants, Dose Expansion: HER2+ Gastric Cancer or Gastro-esophageal Junction Participants |
Primary outcome
Recommended Phase 2 Dose (Part 1)
Time frame: Up to 24 months
Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics
Objective Response Rate (Part 2)
Time frame: Up to 24 months
Anti-tumor activity will be assessed by RECIST 1.1
3 secondary outcomes
Objective Response Rate (Part 1)
Time frame: Up to 24 months
Plasma Concentrations of IKS014 (Part 1 and 2)
Time frame: Up to 48 months
Evaluation of the immunogenicity of IKS014 (Part 1 and 2)
Time frame: Up to 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
Not yet recruiting
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
Breast Cancer
Recruiting
A Study of Skipping Radiation Therapy in People With Breast Cancer
HER2-positive Breast Cancer, Breast Cancer
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James O'Leary, MD study director
Iksuda Therapeutics
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IKS014 in people with Breast Cancer and Gastric Cancer, run by Iksuda Therapeutics Ltd. at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Australia, United States, Singapore, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Browning (+1-615-975-7776, david.browning@iksuda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase 2 Dose (Part 1) (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.