Phase I Clinical Trials & Experimental Therapeutics

Phase I clinical trials at the HICCC

The Phase I Clinical Trials Program at the Herbert Irving Comprehensive Cancer Center (HICCC) leads the earliest testing of new cancer treatments in people. Our experienced Phase I clinicians and research teams guide patients through carefully designed early-phase clinical trials that offer access to promising investigational therapies and help advance cancer care. 

Phase I clinical trials test new cancer treatments in people for the first time. These early-phase studies give eligible patients access to promising investigational therapies while helping advance future cancer care.

What sets our Phase I program apart

  • Experienced leadership in early-phase research: Our investigators lead and participate in a broad portfolio of early-phase clinical trials across many cancer types, including national and multicenter studies. 
  • Coordinated, team-based care: Phase I trials are closely integrated with multidisciplinary cancer care teams across Columbia, with dedicated research nurses and clinical trial navigators guiding patients through each step. 
  • Precision-guided trials: Many studies are informed by genomic and molecular profiling, helping match patients to therapies based on the biology of their cancer. 
  • Discovery-to-clinic pipeline: Select Phase I trials originate directly from discoveries made by Columbia scientists, enabling new treatments to move efficiently from the laboratory to patient care.

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For patients  | For referring providers | For collaborators & industry partners

Explore our trials

For patients

What is a Phase I clinical trial?

Phase I clinical trials are often the first opportunity for patients to access new cancer therapies that are not yet widely available. These studies help doctors learn the best way to give a promising new therapy to patients, including the best dose and schedule, while keeping a close eye on side effects.  

A common misconception is that Phase I clinical trials are only an option for patients who have tried every standard treatment first. This is not always true. Some Phase 1 trials are open for patients earlier in their care, including people who have had few or even no prior treatment, especially if the trial is a good match for their type of cancer.  

Phase I cancer trials are not randomized, which means everyone who joins gets the new drug, rather than the standard drug. Some trials also use tumor testing (like genetic or molecular testing) to help match patients to a treatment that is best suited for the specific features of their cancer.  

Phase I trials focus on: 

  • Finding the safest and most effective dose and schedule 
  • Understanding side effects and how the treatment works in the body 
  • Looking for early signals that the therapy may help against the cancer

Types of treatments studied in Phase I trials

Why consider a Phase I trial?

Potential benefits include: 

  • Access to the newest and most promising cancer therapies 
  • Highly personalized treatment strategies based on tumor biology 
  • Intensive safety monitoring and supportive care 
  • Close follow-up with a specialized early-phase care team

How can I join a Phase I trial?

You may be referred to a Phase I clinical trial by your doctor, or you can explore available studies through our clinical trial listings. Eligibility varies by study and is based on factors such as diagnosis, prior treatments, and other study-specific criteria. 

The evaluation process may include: 

  • Review of medical history and prior treatments 
  • Assessment of eligibility criteria specific to each trial 
  • Molecular or genomic testing, when required 

You do not need to be an existing patient to be evaluated – our clinical trial nurse navigators will help you through the enrollment process.

Explore current Phase I clinical trials

The patient journey: What to expect

1) Getting started: referral or self-referral 

If you are interested in a Phase I trial, you can be referred by your oncologist or reach out to us directly. Once we hear from you, our team will contact you and explain next steps. 

To review your case, we will ask for key medical records, which may include: 

  • Recent scans (CT, MRI, PET) 
  • Pathology reports 
  • Treatment history and clinic notes 
  • Lab results and any tumor testing you’ve already had 
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2) Early review: what Phase 1 trials may work for you 

Our Phase I team will look over your records to see whether a Phase I trial may be a good option and what studies could be a match for you. 

At this step, we may: 

  • Confirm general trial requirements (diagnosis, prior treatments, overall health) 
  • Check insurance and help guide any needed authorizations 
  • Recommend timing, including waiting if something needs to improve first (for example, a lab value, recovery from a recent treatment, or finishing a planned therapy) 

If there are some Phase I clinical trial options for you, we will schedule a new patient visit.

3) First visit: meet the Phase 1 team 

At your first appointment, you will meet with a Phase 1 specialist and learn what early-phase trials involve. Together, we will: 

  • Review Phase 1 clinical trials you may qualify for 
  • Talk through risks, possible benefits, and time commitment 
  • Answer questions about visits, labs, scans, and side effects 
  • Coordinate with your primary oncologist so everyone stays on the same page 

If you decide to move forward, we will review the informed consent form with you. This explains what will happen in the study, your rights, and what’s expected of you. You can take time to read it, ask questions, and decide. You can also choose to stop at any time.

4) Screening: making sure the trial is safe and appropriate for you 

After consent, most trials include a screening period. This is when we confirm that the study is safe and appropriate for you. 

Screening may include: 

  • A physical exam and detailed medical review 
  • Bloodwork and other lab tests 
  • Imaging (scans) and sometimes heart testing (like an EKG or echocardiogram) 
  • Other tests required by the specific trial

5) Treatment and follow-up 

If you are eligible for the trial after screening, treatment can begin. Before you start, we will give you clear instructions about: 

  • How often you need to come in 
  • What happens at each visit (labs, exams, questionnaires, scans) 
  • What symptoms to report right away and who to contact 24/7 

During the trial, you will be closely monitored with regular visits, labs, and imaging. We also stay in close contact with your primary oncology team throughout your care. 

For referring providers

We work in close partnership with referring oncologists and care teams to identify appropriate early-phase clinical trial options for patients and to ensure seamless, coordinated care throughout trial participation. 

Our Phase I team views referring providers as essential collaborators. We prioritize clear communication, efficient navigation, and shared decision-making so that patients can access investigational therapies while remaining connected to their primary oncology team.

Why refer to HICCC Phase I trials?

  • Access to a broad portfolio of early-phase trials, including first-in-human, biomarker-driven, and combination studies across a wide range of cancer types 
  • Expertise in molecular and genomic trial matching, supporting precision-based referral decisions 
  • Phase I investigators with national leadership roles in early drug development 
  • A hands-on intake and navigation process that minimizes administrative burden for you and your patients

How to refer a patient?

Referrals can be initiated by contacting our Phase 1 team.

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Our process includes: 

  • Rapid review of medical records and prior treatment history 
  • Coordination of pathology, imaging, and molecular testing as needed 
  • Pre-screening for multiple trials to identify the best potential fit 

Patients may also self-refer; we coordinate directly with referring providers once contact is established.

Staying involved in your patient’s care

We are committed to maintaining continuity and collaboration throughout a patient’s participation in a Phase I trial. 

  • Regular communication regarding enrollment, treatment milestones, and clinical status 
  • Collaboration on supportive care and symptom management 
  • Clear transition planning when a trial concludes 

Our goal is to complement your care and expand therapeutic options for your patients.

For collaborators & industry partners

The Phase I Clinical Trials Program at the Herbert Irving Comprehensive Cancer Center provides a robust academic platform for early drug development, grounded in translational science and clinical rigor. 

We partner with pharmaceutical and biotechnology companies, contract research organizations, and academic investigators to advance innovative cancer therapies from first-in-human studies through later-stage development.

Why partner with HICCC?

  • Deep integration with translational research, enabling biologically informed trial design and correlative science 
  • Investigators with recognized expertise and national leadership in early-phase oncology trials 
  • Experience serving as lead and national principal investigators on multicenter studies 
  • Efficient trial execution supported by dedicated Phase I infrastructure 
  • Strong academic output that informs later-stage development 
  • Experienced, collaborative teams, including physician investigators, research nurses, and clinical coordinators with deep expertise in early-phase trials 
  • Focused and efficient portfolio, allowing close oversight, rapid decision-making, and high-quality data

Our capabilities

  • First-in-human and dose-escalation trials 
  • Biomarker- and molecularly driven study designs 
  • Combination strategies with standard therapies 
  • Embedded translational and correlative endpoints 
  • Investigator-initiated trials originating from Columbia research 

Our program functions as the clinical investigational arm of Columbia’s translational research enterprise, providing a direct pathway from laboratory discovery to clinical application.

Opportunities for collaboration

We welcome discussions related to: 

  • Early-phase trial development and execution 
  • Investigator-initiated studies 
  • Translational and correlative research partnerships 
  • Strategic advisory roles in early drug development 

Interested in partnering with us? Contact our Experimental Therapeutics leadership team to explore collaboration opportunities.

Contact the Phase I team

Whether you are a patient, referring provider, or potential collaborator, we welcome the opportunity to connect.

212-342-5162 | cancerclinicaltrials@cumc.columbia.edu | Clinical trials information request form

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