New clinical trial in Kenya could move needle in cancer treatment

Diana Omare, a research nurse adjusting an infusion pump at the unit. [Gloria Milimu, Standard]

A new clinical trial to investigate the effectiveness of a novel cancer drug could drastically change how one of the most devastating global health challenges is managed in Kenya and beyond.

The trial which targets what researchers at the Aga Khan University Hospital in Nairobi are calling “the housekeeping gene”, is using cutting-edge technology to study whether the drug could safely and effectively block the mutation of a gene into a cancer-causing variant.

The gene is scientifically known as KRAS and is involved in the regulation of cell division as a result of its ability to relay external signals to the cell nucleus.

Prof Mansoor Saleh, director of the Clinical Research Unit at Aga Khan says while KRAS is found in all cells of the body and is responsible for the growth and survival of normal cells “sometimes its activation may become uncontrollable, resulting in uncontrolled growth, which may lead in some cases to cancer.”

At least 40 participants are taking part in the study, including one woman whom we shall refer to as Olivia to protect her identity. Through their efforts and sacrifices, they are giving hope for new treatment options for people diagnosed with tumours.

Ms Olivia, who lives in Nairobi, was diagnosed with Stage 3 breast cancer in 2023.

“The diagnosis came as a shock to me, so when I was approached to participate in the trial, it was a no-brainer for me given that it presented an opportunity for me to be part of a study that would not only benefit me but also other women,” she says.

Although such clinical trials may seem intimidating at first, scientists and researchers say they give a ray of hope to those already diagnosed with cancer. Ms Olivia recalls being anxious the first time she received her first dose of the “future drug”. But now, as the anxiety wears off, she looks forward to what she hopes will be a positive outcome from the study.

At the centre of the science are tests to determine whether the drug could prevent the KRAS gene from mutating into KRAS G12C, which Prof Saleh says is responsible for the development of lung, colon and other types of cancers.

The pill Olivia and the other members of the test group are taking is called GDC 6036 and was developed by Roche Pharmaceuticals, and Prof Saleh say that should it work, it would present “a good sign that we can treat cancer early based on what we call precision oncology”.

Prof Mansoor Saleh, Director of Clinical Research, CRU, AKUH. [Gloria Milimu, Standard]

Additionally, he says, such clinical trials are fundamental in the production of therapies that respond better to the genetic specifications of African populations.

Clinical trials have at least four phases, all of which monitor for safety and adverse events in trial patients.

Phase I trials determine the dose which will be least toxic to the patient, Phase II checks whether the least toxic dose is effective, Phase III compares the new drug with what is currently available, and Phase IV, also known as post-marketing or therapeutic use studies, investigates rare but serious side effects that the new drug or therapy might cause.

Whereas scaling up trials in Africa is considered to be critical in strengthening healthcare interventions and improving access to lifesaving medicines and vaccines, experts reckon that of the 736 clinical trials conducted in Africa, only 26 per cent are cancer-related. Critically, only six per cent of these were conducted in countries with predominantly black patients.

Over the years, pharmaceutical companies have been slow in embracing sub-Saharan Africa for the conduct of clinical trials, with most non-communicable disease clinical trials from the continent being conducted in Egypt or South Africa.

“There are drugs that the African genome does not metabolise properly, that means; a small dose for a Caucasian patient may be a high dose for an African patient,” says Prof Saleh, who is also an oncologist.

He further adds that the side effects of a drug or its benefits might differ, hence the need to do clinical trials in Africa and on Africans as opposed to depending on results from the West.

Factors such as lack of established clinical trial units with trained personnel, willingness to take part in trials, and prolonged and often replicative regulatory processes hamper clinical trials in Africa.

In Kenya, where doctors record at least 42,000 new cases of cancer annually and an additional 27,000 cancer-related deaths in the same period, the need to invest more in clinical research is particularly urgent.

They are the heart of all medical advances and the last hope for patients like Olivia and many others diagnosed with serious conditions like cancer.